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1 | PUBLISHER | REGISTRATION (Prospective) | REGISTRATION (Retrospective) | RESULTS (Prospective) | RESULTS (Retrospective) | CSRs (Prospective) | CSRs (Retrospective) | IPD | |||||||||||||||||||||||||||||||||||||||||
2 | Company name | Estimated sales (converted to USD) | Known for | Do they have a policy to register all trials (excepting specific exclusions in later columns) from now? | Do they say they conduct any kind of audit of compliance with their registration policy? (If they don't mention it, then no.) | If they do conduct an audit of compliance, do they share the summary results of this audit publicly? | If they do conduct an audit of compliance, do they share the line by line individual trial data from this audit publicly? (That is: the names of trials, and then whether they were in compliance with the policy, or not.) | Does the policy include phase 4 trials? If they say "all" then this is assumed to include phase 4. | Does their current policy describe the registration policy covering past trials? | From what date does this policy apply? (Give explanation of how year is used eg "trials initiated after 2001" or "trials used in regulatory approval since 2003" etc, or if not other details given then "200x NOS" [not otherwise specified]). This date is normalised after the second "/" to permit comparisons between companies. The average duration of a clinical trial is 2 years, as per Pregelj 2015. Therefore we normalise to NOS date. If a company commitment is "trials initiated after 2010" then this becomes "2011", if the commitment is "trials completing after 2012" then this becomes "2011", and so on. Whole years are used for simplicity. | Do they have a policy to make all summary results available? (Excepting specific exclusions in later columns). | Do they commit to post summary results on pre-specified primary and secondary outcomes to clinicaltrials.gov within 12 months of completion? (Here, we are strict on 12 months, because without a time commitment there is effectively no commitment; where there is a longer time commitment, we give no and specify the delayed time period in a comment. If a company only says it commits to comply with legislation they get "no" here, as legislation does not cover all trials.) | Do they commit to post summary results to their own website within 12 months of completion? (Note same conditions on "within 12 months" apply as for posting results on clinicaltrials.gov). | Do they commit to submit all trial results to an academic journal within 12 months of completion. (This cannot be with caveats, eg "we submit all medically important results" scores "no"). | Does this commitment to post summary results include unlicensed treatments? | Does this commitment to post summary results include unlicensed uses of licensed treatments? (In the absence of a clear commitment either way: if the company does not post summary results on unlicensed treatments, the answer on unlicensed uses of licensed treatments is assumed to also be "no"; if the company has a clear theme of "all" trials throughout their policy, then the answer is assumed to be "yes"). | Does this commitment to post summary results include phase 4 trials? (In the absence of a clear commitment either way, if there is a clear theme of "all" throughout the policy document, for example if they have made commitments to phase 2-4 trials for other aspects of their policy and there is no reason to believe that this issue would be an exception to that, then this is "yes"). | Does their current policy cover results of past trials, committing to make all results available (excepting specific exclusions in later columns)? If this commitment is only for a poorly defined subset of trials, such as "medically important results", this is coded as "no". | Do they commit to post summary results of all past trials (excepting specific exclusions in later columns) on pre-specified primary and secondary outcomes to clinicaltrials.gov? (Note this does not require a 12 month criteria for posting results). | Do they commit to post summary results of all past trials (excepting specific exclusions in later columns) to their own website? (Again, the retrospective commitment does not include a "within 12 months" requirement). | Do they commit to submit all trials to an academic journal. (Note this must be all trials, not "all interesting trials" etc). | Does this commitment to posting summary results of past trials include trials on unlicensed treatments? | Does this commitment to posting summary results of past trials results include unlicensed uses of licensed treatments? (In the absence of a clear commitment either way: if the company does not post summary results on unlicensed treatments, the answer on unlicensed uses of licensed treatments is assumed to also be "no"; if the company has a clear theme of "all" trials throughout their policy, then the answer is assumed to be "yes"). | Does this commitment to post summary results of past trials include phase 4 trials? (In the absence of a clear commitment either way, if there is a clear theme of "all" throughout the policy document, for example if they have made commitments to phase 2-4 trials for other aspects of their policy and there is no reason to believe that this issue would be an exception to that, then this is "yes"). | From what date does this policy on posting summary results for all trials apply? (Give explanation of how year is used eg "trials initiated after 2001" or "trials used in regulatory approval since 2003" etc, or if not other details given then "200x NOS" [not otherwise specified]). This date is normalised after the second "/" to permit comparisons between companies. The average duration of a clinical trial is 2 years, as per Pregelj 2015. Therefore we normalise to NOS date. If a company commitment is "trials initiated after 2010" then this becomes "2011", if the commitment is "trials completing after 2012" then this becomes "2011", and so on. Whole years are used for simplicity. For "drugs approved after year x" an additional year is added. So "approved after 2013" would normalise to "2011". There is no perfect method to make dates comparable between companies. | Do they have a policy on sharing Clinical Study Reports (CSRs) at all? | Do they commit to share CSRs? | Is access to CSRs on request only, rather than prospectively posting CSRs online? (If only on request, summarise in comment how onerous the request process is, e.g. is it the same high level of workload as for a full IPD request, with extensive review of request and requesters; or is this just being used to prioritise which CSRs to share by the company?) | Spare coding space for CSR issues [not currently used]. | Does this commitment to sharing CSRs include trials on unlicensed treatments? | Does this commitment to sharing CSRs include unlicensed uses of licensed treatments? (In the absence of a clear commitment either way: if the company does not share CSRs on unlicensed treatments, the answer on unlicensed uses of licensed treatments is assumed to also be "no"; if the company has a clear theme of "all" trials throughout their policy, then the answer is assumed to be "yes"). | Does the policy commit to sharing synopses only? (This means: are synopses the only part of the CSR ever made available? If actual CSRs are available on request, and the synopses are routinely published, then this field is coded "no", and the CSR sharing policy is coded as for their policy on sharing CSRs proper). | Does their current policy cover CSRs of past trials? | Is access to CSRs on request only, rather than prospectively posting CSRs online? (If only on request, summarise in comment how onerous the request process is, e.g. is it the same high level of workload as for a full IPD request, with extensive review of request and requesters; or is this just being used to prioritise which CSRs to share by the company?) | Does this commitment to sharing past CSRs include trials on unlicensed treatments? | Does this commitment to sharing past CSRs include unlicensed uses of licensed treatments? (In the absence of a clear commitment either way: if the company does not share CSRs on unlicensed treatments, the answer on unlicensed uses of licensed treatments is assumed to also be "no"; if the company has a clear theme of "all" trials throughout their policy, then the answer is assumed to be "yes"). | Does the policy commit to sharing synopses only? (This means: are synopses the only part of the CSR ever made available? If actual CSRs are available on request, and the synopses are routinely published, then this field is coded "no", and the CSR sharing policy is coded as for their policy on sharing CSRs proper). | From what date does this policy on sharing CSRs apply? (Give explanation of how year is used eg "trials initiated after 2001" or "trials used in regulatory approval since 2003" etc, or if not other details given then "200x NOS" [not otherwise specified]). Note after the second "/" this date is normalised, as per previous date column. "Filed with regulator" assumed to be same as "completed". | Details on additional exclusions and redactions regarding CSR sharing may be posted here, but the definitive source is the full text of the policy. | Do they have a policy to make individual patient data (IPD) from clinical trials available on request? | From what date does this policy on sharing IPD apply? (Give explanation of how year is used eg "trials initiated after 2001" or "trials used in regulatory approval since 2003" etc, or if not other details given then "200x NOS" [not otherwise specified]). Note after the second "/" this date is normalised, as per previous date column. "Filed with regulator" assumed to be same as "completed". | Does this commitment to sharing IPD include trials on unlicensed treatments? | Does this commitment to sharing IPD include unlicensed uses of licensed treatments? (In the absence of a clear commitment either way: if the company does not share IPD on unlicensed treatments, the answer on unlicensed uses of licensed treatments is assumed to also be "no"; if the company has a clear theme of "all" trials throughout their policy, then the answer is assumed to be "yes"). | Does the policy include phase 4 trials? If they say "all" then this is assumed to include phase 4. | Are there any additional exclusions? (For IPD sharing the answer is almost always "yes"). | Do they say they consider requests for IPD on additional trials not explicitly covered by their policy? | Details on additional exclusions and redactions regarding IPD sharing may be posted here, but the definitive source is the full text of the policy, and a structured review of all restrictions in IPD sharing policies is beyond the scope of this audit. | Changes since 2015? Notes. | |
3 | Abbott | $21bn | Femelle, Geptor, Quetidin | UNCLEAR / This is a difficult edge case, but they appear to only be promising to adhere to the law, which may not cover all trials. They set up the subset of trials covered by their policy with the phrase "Our registrations and results disclosures will adhere to all applicable national laws and regulations in countries where we operate, around the world." They then state: "Abbott will register all applicable/covered clinical trials, regardless of outcome, in a publicly accessible clinical trials registry, such as www.ClinicalTrials.gov. For branded generic pharmaceuticals, this means that we will register interventional clinical studies in patients. For medical devices and diagnostics, this means we will register interventional clinical studies of health outcomes and pediatric post-marketing surveillance studies, as designated by national laws and regulations." They only commit to register "all applicable" trials, this phrase is not clearly defined, and can only be read as a reference to the preceeding paragraph that refers to "all applicable national laws and regulations". | UNCLEAR / As per registration, this appears to be restricted to compliance with legislation only. "Our registrations and results disclosures will adhere to all applicable national laws and regulations in countries where we operate, around the world." Then: "Abbott will disclose the results of all applicable/covered clinical trials, regardless of outcome, in a publicly accessible clinical trials results database, such as www.ClinicalTrials.gov. For branded generic pharmaceuticals, this means that we will report results for interventional clinical studies in patients. We also will report the results of any exploratory pharmaceutical clinical studies if the findings have significant medical importance (e.g., an important safety finding). For medical devices and diagnostics, this means we will report results for interventional clinical studies of health outcomes and pediatric post-marketing surveillance studies, as designated by national laws and regulations." We take this to mean they are committing to comply with legislation. This is somewhat complicated by the fact that a separate web document states "The database contained the results from all "hypothesis-testing" clinical studies (mainly Phase III and IV studies) completed since October 1, 2002, for drug products approved in the United States" referring to the PhRMA Clinical Study Results Database: however this only ran from 2004 to 2011, and there is no subsequent clear commitment, and no prospective commitment, other than that with the caveat as above. Therefore this remains a difficult edge case. | no | no | " In an evolving regulatory environment around sharing clinical trial data for research purposes, Abbott will continue to engage with stakeholders regarding approaches for sharing clinical trial data with scientific and medical researchers to advance medical science, while protecting information that is confidential for patients, our partners and our company. " | |||||||||||||||||||||||||||||||||||||||||
4 | AbbVie | $26bn | Humira, Kaletra, Lupron | yes | no | no | no | yes | YES | 2004 NOS / 2004 | yes | no | no / for CSR synopses the commitment is 18 months | NO / Here there are conflicting documents. The Abbvie pdf "AbbVie’s Approach to Implementing the PhRMA-EFPIA Principles for Responsible Clinical Trial Data Sharing" says “At a minimum, results from all Phase 3 clinical trials and any clinical trials of significant medical importance should be submitted for publication.” However their website says http://www.abbvie.com/research-innovation/clinical-trials-data-and-information-sharing/publications.html "AbbVie will submit a manuscript to a peer-reviewed scientific/medical journal for all AbbVie-sponsored interventional clinical trials conducted in patients using AbbVie marketed products or investigational compounds (including compounds for an indication whose development program has been discontinued). " (with no restrictions by phase). | no / They are not explicit about doing so and there are caveats throughout their policy making clear that specific parts of it apply only to marketed products and currently licensed uses. Therefore this must be coded NO. | no / as for unlicensed. | YES / no evidence of restrictions on grounds of phase. | yes | no | yes / eg as CSR synopses | no / Here there are conflicting documents. The Abbvie pdf "AbbVie’s Approach to Implementing the PhRMA-EFPIA Principles for Responsible Clinical Trial Data Sharing" says “At a minimum, results from all Phase 3 clinical trials and any clinical trials of significant medical importance should be submitted for publication.” However their website says http://www.abbvie.com/research-innovation/clinical-trials-data-and-information-sharing/publications.html "AbbVie will submit a manuscript to a peer-reviewed scientific/medical journal for all AbbVie-sponsored interventional clinical trials conducted in patients using AbbVie marketed products or investigational compounds (including compounds for an indication whose development program has been discontinued). " (with no restrictions by phase). | no | no | YES / no evidence of restrictions on grounds of phase. | 2004 NOS / 2004 | yes | yes | no | no | no | yes / in our experience companies sharing IPD also share CSRs however throughout their policy statements they explicitly only mention CSR synopses. | yes | no | no | no | yes | 2004 NOS / 2004 | yes | "completed as of May 2004" / 2003 | no | no | YES | yes | Yes | Many. Also note: "as long as they are not part of an ongoing or planned regulatory submission. " | ||||
5 | Alkermes | $746mn | Aristada, Vivitrol | no | no | no | no | ||||||||||||||||||||||||||||||||||||||||||
6 | Almirall | $893mn | Monodox, Ebastel, Tesavel and Efficib | yes | no | no | no | YES | yes | 2005 ("Almirall started on public registry of clinical trials on 1st July 2005") / 2005 | yes | yes | no | no | no | no | YES | NO | no | no | |||||||||||||||||||||||||||||
7 | Amgen | $23bn | Enbrel, Neulasta, Aranesp | yes | no | no | no | yes | yes | initiated after or ongoing as of 2007, note US and EU policy start dates are different, therefore we took policy start date as date from when both territories are covered / 2008 | yes | yes | no | unclear / | yes | yes | no | yes | yes | no | unclear | yes | yes | YES | 2007 / 2007 | yes | yes | YES / "Full clinical study reports will be made available for those studies included in an approved data sharing request submitted by external scientific and medical researchers interested in collaborating with Amgen." | no | no | no | yes | yes | NO | NO | NO | missing | only if approved IPD request | yes | missing | unclear | unclear | unclear | unclear | see doc | ||||
8 | Astellas | $12bn | Xtandi, Vesicare, Prograf | yes | no | no | no | yes | yes | None given, therefore Jan 2015, date of document. / 2015 | yes / There is some ambiguity and lack of clarity here, as their policy may be read to cover only trials included in the application package for regulatory approval: "Astellas commits to disclosing summary results of all Astellas sponsored phase 1 to phase 4 interventional trials, in patients, that seek to evaluate the safety and efficacy profile for Astellas products that have regulatory approval. This policy applies to products that receive regulatory approval after January 1, 2014 consistent with the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) principles for responsible clinical trial data sharing dated July 18, 2013, and includes the summary results for trials covered under this policy and included in the application to support regulatory approval." However overall our reading of this is "all". | no / no timeline given, but do commit to share "Astellas commits to disclosing summary results of all Astellas sponsored phase 1 to phase 4 interventional trials, in patients, that seek to evaluate the safety and efficacy profile for Astellas products that have regulatory approval." | no | no | no | no | YES | YES | UNCLEAR / Unclear because they don't say where: "Summary results will be posted on a publicly available website, including national clinical trial databases as and when required by law or regulation." | UNCLEAR | no | no | UNCLEAR | YES | COMPLETED OR APPROVED AFTER JAN 1 2014 | yes | yes | yes / Not prospective sharing: laborious application process, like IPD. | no / Must be approved in *both* US and EU. | no | no | yes | yes | no | no | no | completed after 2010 AND APPROVED IN BOTH US AND EU! / 2012 | as IPD | yes | completed after 2010 AND APPROVED IN BOTH US EU / 2008 | no | no | yes | yes | yes | see doc | |||
9 | AstraZeneca | $23bn | Crestor, Symbicort, Nexium | yes | no | no | no | yes | yes | 2010 NOS / 2010 | yes | YES / AZ’s policy document makes a number of commitments on posting summary results within 12 months, spread over various parts of the document. These commitments are longstanding (“Since 2005, we have posted results of trials with already marketed medicines within one year of completion”). They commit to sharing results on EUCTR within 12 months (although this register, similar to ct.gov in its results-reporting facility, only permits entries for trials within the EUCTR criteria, while ct.gov permits any trial to be entered). AZ also commit to sharing results on ct.gov: “Since 2007 we have posted results as required on the US National Library of Medicine’s website and other sites as required by law.”. The interpretation of the phrase “as required” could be interpreted to either mean (a) compliance with the law (in which case they would not score, as discussed in the question text) or (b) as required by their policy. We took it to be the latter, especially since “as required by law” is included as a separate element elsewhere in the sentence, where it is used apparently in relation to other sites. This is a close call, made under our principle of assuming good faith when reading policy documents. | Yes / They say they will post this information within a year. It is not consistently made clear where, but appears to be to their own site. | no | no | no | YES | yes | UNCLEAR / "Since 2007 we have posted results as required on the US National Library of Medicine’s website and other sites as required by law" however there is an additional commitment to "all". | YES | no | no | no | YES | Completed after Jan 2005 / 2004 | YES | UNCLEAR / APPARENTLY ONLY WHAT EU REGULATIONS REQUIRE | UNCLEAR | UNCLEAR | UNCLEAR | NO | UNCLEAR | UNCLEAR | UNCLEAR | UNCLEAR | NO | yes | 2009 NOS / 2009 | unclear | unclear | unclear | unclear | yes | see doc and site | |||||
10 | Bayer | $47bn | Xarelto, Eylea, Kogenate | yes | yes / "Bayer has implemented a thorough monitoring and quality control process to ensure that high standards for transparency of clinical trial information for Bayer medicines are fully met and that information on clinical trials as outlined in this policy is publicly disclosed in time and is of high quality. " | no | no | yes | yes | trials started after 2005 / 2005 | yes | NO / Timeline commitment is not firm: "The study result information is usually available within 12 months of the trial completion date. " | NO / Timeline commitment is not firm: "The study result information is usually available within 12 months of the trial completion date. " | no | NO | NO | yes | yes | yes | yes | no | NO | NO | yes | completed after JULY 2005 / 2004 | yes | yes | yes / Laborious application process like IPD. | no / "Trials in patients sponsored by Bayer that have been submitted to the US and EU regulatory agencies as part of the request for marketing authorization for new medicines and indications" | no | no | yes | yes / LABORIOUS LIKE IPD | no | no | no | products approved IN BOTH EU AND US after 2014... Trials in patients sponsored by Bayer that have been submitted to the US and EU regulatory agencies as part of the request for marketing authorization for new medicines and indications / 2012 | as ipd NOTE EXCLUDES PH4, and: "Trials in patients sponsored by Bayer that have been submitted to the US and EU regulatory agencies as part of the request for marketing authorization for new medicines and indications" | yes | products approved IN BOTH EU AND US after 2014, "Trials in patients sponsored by Bayer that have been submitted to the US and EU regulatory agencies as part of the request for marketing authorization for new medicines and indications" / 2012 | no | no | no | yes | yes | see doc | |||
11 | Biogen | $11.5bn | Tecfidera, Tysabri, Avonex | yes | no | no | no | yes | NO | yes | yes / they do one or more of all 3 of these methods, and within one year. | NO / they do one or more of all 3 of these methods, and within one year. | NO / they do one or more of all 3 of these methods, and within one year. | no | no | unclear | yes | yes | NO | NO | no | no | unclear | 2005 / 2005 | yes | yes | yes / LABORIOUS PROCESS LIKE IPD | no | no | no | yes | yes | no | no | no | products and indications approved IN BOTH EU AND US after 2014 / 2012 | yes | products and indications approved IN BOTH EU AND US after 2014 / 2012 | no | no | unclear | unclear | UNCLEAR | seems to require registrtation to find out policy | |||||
12 | Boehringer Ingelheim | $17.5bn | Spiriva, Pradaxa, Micardis | yes | no | no | no | yes | yes | STUDIES INITIATED AFTER JAN 1998 / 1999 | yes | yes | yes | no | no | no | YES | yes | yes | yes | yes | no | no | YES | initiated after 1998 / 1999 | yes | yes | yes / "based on a brief ‘Document Sharing Agreement’, which requires, in particular, the re- questor’s commitment to use the documents only for scien- tific purposes and to not misuse it, e.g., for their own or third party’s commercial interests or in support of generic or other competitive marketing authorization applications or other regulatory proceedings." | unclear | unclear | no | yes | yes | unclear | unclear | no | initiated after 1998 / 1999 | "after regulatory review has been completed or after termination of the development program and once the primary manuscript describing the results has been accepted for publication. " | yes | initiated after 1998 / 1999 | unclear | unclear | unclear | yes | YES | see doc | |||
13 | Bristol-Myers Squibb | $19.5bn | Eliquis, Sprycel, Daklinza | yes | no | no | no | yes | NO | yes | no / no timeline, no reference to legislation | no | no | no | no | yes | yes | yes | yes | yes / all ph3+4 submit | no | no | yes | completed after 2008 / 2007 | yes | yes | yes / LABORIOUS PROCESS LIKE IPD | no | no | no | yes | yes | no | no | no | completed after 2008 / 2007 | as ipd | yes | completed after 2008 / 2007 | no | no | yes | yes | unclear | see doc | ||||
14 | Celgene | $11bn | Revlimid, Pomalyst, Abraxane | yes | no | no | no | yes | no | UNCLEAR / There are several layers of caveat, including: it's only those trials covered by a legal obligation; only those trials submitted as part of approval package; only lay summaries (which may not be comprehensive descriptions of methods and results): "Results Posting on Clinical Trial Registry Public Websites Celgene posts on public websites the trial progress and results of Celgene- sponsored studies as required by national and regional regulations. Clinical Study Report Synopses Celgene posts on public websites the redacted Clinical Study Report synopses for studies supporting indications approved in both the United States and European Union on or after January 1, 2014. Lay Summaries to Study Participants Within a year of the end of the trial, Celgene will provide lay summaries from all Celgene-sponsored studies in patients that were initiated on or after January 1, 2014 to inform and educate patients about their clinical trial participation." | no | no | no | no | no | no | UNCLEAR / There are several layers of caveat, including: it's only those trials covered by a legal obligation; only those trials submitted as part of approval package; only lay summaries (which may not be comprehensive descriptions of methods and results): "Results Posting on Clinical Trial Registry Public Websites Celgene posts on public websites the trial progress and results of Celgene- sponsored studies as required by national and regional regulations. Clinical Study Report Synopses Celgene posts on public websites the redacted Clinical Study Report synopses for studies supporting indications approved in both the United States and European Union on or after January 1, 2014. Lay Summaries to Study Participants Within a year of the end of the trial, Celgene will provide lay summaries from all Celgene-sponsored studies in patients that were initiated on or after January 1, 2014 to inform and educate patients about their clinical trial participation." | UNCLEAR | UNCLEAR / THEY SAY THEY'RE GOING TO POST "ON PUBLIC WEBSITES" | NO | NO | NO | NO | 2014 INCONSISTENT: for synopses, it's CSR synopses (for studies in marketing approval pack only) for products approved in US and EU after jan 1 2014; for lay summaries it's trials initiated after jan 1 2014 / unclear | yes | yes / with caveats as per IPD access | yes / LABORIOUS PROCESS LIKE IPD | no | no | no | yes | yes / onerous and subject to approval | no | no | no | trials for indications approved after 2014 / 2012 | as ipd | yes | "studies supporting indications approved in both the United States and European Union on or after January 1, 2014" / 2012 | no | no | unclear / probably not: "studies supporting indications approved in both the United States and European Union on or after January 1, 2014" | yes | yes | see policy | ||||
15 | Daiichi Sankyo | $9bn | Olmetec, Effient, Lixiana, Benicar | YES / "To ensure transparency we disclose information relating to our clinical studies in accordance with the regulations of the respective country, the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases" therefore inherit joint position score: note all other companies making allusion to this document either exceed the commitments of the Joint Position, or fall short on specifically described elements, or don't make a clear commitment to adhere to it. | no | no | no | yes | UNCLEAR | MISSING You cannot inherit a start date by stating compliance with a joint position | yes | no | yes / "results should be posted no later than one year after the medicinal product is first approved and commercially available in any country." | no | no | no | unclear | UNCLEAR | yes | yes | yes / laborious and through CSDR | no | no | no | yes | yes / approval thru CSDR | no | no | no | "studies in patients that form part of the submission package for medicines and indications approved in the United States (US) and the European Union (EU), after 1 January 2014" AND: "Studies are listed after the medicine and indication have received EU and US marketing approval, on or after the 1 January 2014 and after the results from the studies have been accepted for publication." / 2012 | "Daiichi Sankyo will list Phase 2, Phase 3 and Phase 4 Daiichi Sankyo-sponsored interventional clinical studies in patients that form part of the submission package for medicines and indications approved in the United States (US) and the European Union (EU), after 1 January 2014" | yes | "studies in patients that form part of the submission package for medicines and indications approved in the United States (US) and the European Union (EU), after 1 January 2014" AND: "Studies are listed after the medicine and indication have received EU and US marketing approval, on or after the 1 January 2014 and after the results from the studies have been accepted for publication." / 2012 | no | no | yes | YES | yes | see policy | ||||||||||
16 | Dainippon Sumitomo | $3.8bn | Latuda, Brovana, Meropen | no | no | no | no | ||||||||||||||||||||||||||||||||||||||||||
17 | Eisai | $5bn | Aricept, Aloxi, Methycobal | yes | no | no | no | yes | no | yes | no | no / no timeline given | no | no | no | UNCLEAR | no | yes | yes | yes / thru CSDR or to Eisai directly "Eisai can provide access to full clinical study reports from Eisai sponsored trials on request. Please contact Eisai directly by clicking on the icon below to request access to clinical study reports and any other associated information." also: "For products and indications submitted and approved by EMA and FDA" | no | no | no | yes | yes | no | no | no | "- For products and indications submitted and approved by EMA and FDA, after 1st January 2014 and only after the primary manuscript describing the results has been accepted for publication. " | POTENTIAL UNREASONABLE EXCLUSION IF THIS APPLIES TO CSRs ALSO: "Data will be shared for trials included in dossiers submitted to and approved by FDA and EMA after 1st January 2014 and only after the primary manuscript describing the results has been accepted for publication, and only if clinical data disclosure will not lead to commercial competitive risk. In all cases data will not be shared if the privacy of patients cannot be safe guarded." | yes | "For products and indications submitted and approved by EMA and FDA, after 1st January 2014 and only after the primary manuscript describing the results has been accepted for publication. " / 2012 | no | no | yes | yes | yes | see https://www.clinicalstudydatarequest.com/Study-Sponsors-eisai-Details.aspx and "Data will be shared for trials included in dossiers submitted to and approved by FDA and EMA after 1st January 2014 and only after the primary manuscript describing the results has been accepted for publication, and only if clinical data disclosure will not lead to commercial competitive risk. In all cases data will not be shared if the privacy of patients cannot be safe guarded." | |||||||||||
18 | Eli Lilly | $21bn | Humalog, Cialis, Alimta | yes | no | no | no | UNCLEAR | yes | 2004 NOS / 2004 | yes / BECAUSE OF SYNOPSES POLICY | no | no / no timeline given | no | NO | NO | yes | yes | no | yes | no / ONLY COMMIT ON PH3 | no | no | yes | started after 2002 / 2003 | yes | yes | yes / LABORIOUS PROCESS LIKE IPD | no | no | no | yes | yes | no | no | no | started after 2007 IF SYNOPSES ONLY THEN 2002 / 2008 | yes | 2014 BUT CAN BE SAID TO GO BACK FURTHER IF YOU ALLOW FOR RESTRICTIONS LIKE ONLY MULTICENTRE GLOBAL STUDIES / 2014 | no | no | yes | yes | yes | see document | ||||
19 | Esteve | $1bn | Aquoral Forte, Dolomidina, Laxadina | no | no | no | no | ||||||||||||||||||||||||||||||||||||||||||
20 | Gilead | $30.5bn | Harvoni, Sovaldi, Truvada | no | no | no | no | ||||||||||||||||||||||||||||||||||||||||||
21 | GlaxoSmithKline | $35bn | Seretide/Advair, Triumeq, Pediarix Vaccine | yes / BUT ONLY COMMIT TO ON THEIR OWN SITE, OPEN Q OF WHETHER THIS CONSTITUTES REGISTRATION | no | no | no | yes | yes | 2004 NOS / 2004 | yes | no | no | no | yes / "results from completed clinical studies on compounds that are both investigational and approved medicines " | yes | yes | yes | no | yes | yes | yes | yes | yes | 2004 NOS / 2004 | yes | yes | no / proactively posting. | no | UNCLEAR | no | yes | no | no | no | no | 2000 NOS / 2000 | We have committed to publish the CSRs for all new studies on our medicines – both medicines that are approved by regulators and ones that are terminated from development. These will now be included alongside the other study information on our online register. In addition, we are also publishing historic CSRs for clinical outcomes trials for our approved medicines dating back to when GSK was formed in 2000. This is a significant volume of studies and so we have put in place a dedicated team for this programme of work, to retrieve and examine the historic CSRs and remove any confidential patient information. This will happen over the next few years and we are posting the reports in a step-wise manner, starting with CSRs for our most commonly prescribed medicines. | yes | START IN OR AFTER 2013, BUT NOTE COULD HAVE BEEN 2000 IF WILLING TO COUNT "GLOBAL TRIALS" / 2014 | yes | yes | yes | yes / 6 months after publication. (unclear what they do if not published) | yes | Clinical studies where data labels and/or supporting documents are not in English. Clinical studies of rare diseases. This is because anonymisation of these data is more difficult to achieve. For these studies GSK will assess the feasibility of anonymisation as part of the review of enquiries. Clinical studies of GSK Consumer Healthcare products. This is because GSK anticipate more interest from researchers in accessing data from studies of pharmaceutical medicines and vaccines. When patients agreed to take part in GSK clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease GSK were researching. Further research must therefore study the medicine or disease that was researched in the original studies. For studies GSK conduct from 2013, patients will be asked to give permission for broader research so other research may be possible with data from these studies.Whether the studies have been published or accepted for publication and whether they researched terminated or authorised medicines (for approved uses). It is GSK policy to provide access to patient level data after authorisation or termination of the medicine and acceptance of the study for publication in the scientific literature. Whether GSK are able to provide the requested data. For example, the majority of non-interventional (or observational) studies use data from third party databases under licence agreements which prevent GSK from providing access to the data. Researchers can access data directly from these third party databases under similar agreements. Whether GSK have the legal authority to provide the data. For example, GSK may not have the legal authority because the medicine has been out-licensed to another company. Whether GSK consider it feasible to anonymise the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis. Whether GSK consider that there are any practical constraints to providing access to the data. For example, there may be issues related to the size of databases from genetic studies. The resources (costs) for GSK to retrieve data and documents from repositories and archives, anonymise data, and redact personally identifiable information from relevant documents. In some cases, particularly for older studies, the costs could be considerable and GSK may turn down requests on this basis. | |||
22 | Grunenthal | $1.5bn | Versatis, Tramal, Nucynta | no / Only "Meet all relevant national legal requirements... To register clinical trials on freely accessible internet registries, e.g., ClinicalTrials.gov" | no / Only: "Meet all relevant national legal requirements... To disclose clinical trial information (including results) on freely accessible internet registries, e.g., ClinicalTrials.gov. " | yes | yes | yes / LABORIOUS PROCESS LIKE IPD | no | no | no | yes | yes | no | no | no | first protocol approval after 2014 / 2015 | ANOTHER EXCLUSION: HAS TO BE PART OF APPROVAL PACKAGE... Requests for clinical data sharing will be accepted for interventional clinical trials which meet all of the following criteria: • Were conducted in patients. • Were sponsored by Grünenthal. • Had first protocol approval after 15 July 2014. • Were submitted as part of a successful application to the United States Food and Drug Administration, the European Medicines Agency, or a national competent authority of a European Union Member States, for a marketing approval or variation or extension. | yes | first protocol approval after 2014 / 2015 | no | no | yes | yes | yes | Access to patient- or trial-level data will not be granted if any of the following apply: • There is a reasonable likelihood that individual patients could be re-identified. • Access would violate the patients’ informed consent. • Access to patient-level data might jeopardize incentives for future investment in biomedical research. • There are contractual or legal or consent provisions that prohibit the transfer of clinical data to third parties. If co-development agreements or other legal restrictions prohibit the sharing of requested clinical data, summary information will be offered instead (where possible). • Provision of the requested access would cause unacceptable costs. | |||||||||||||||||||||||
23 | Ipsen | $2bn | Somatuline, Decapeptyl, Dysport | yes | no | no | no | yes | yes | 2005 NOS / 2005 | yes | yes / give no time commitment for unapproved products | no | no | NO | NO | yes | yes | yes | no | UNCLEAR | NO | NO | yes | 2005 NOS / 2005 | no | no | ||||||||||||||||||||||
24 | Johnson & Johnson | $72bn | Remicade, Stelara, Zytiga | yes | UNCLEAR | no | no | yes | yes | ongoing or started after 2005 / 2005 | yes | NO / pollicy is to comply with legislation ie not all trials | no | no | UNCLEAR | UNCLEAR | yes | no | yes | yes | yes / LABORIOUS PROCESS LIKE IPD | no | no | no | yes | yes | no | no | no | missing MAYBE ALL / NOTABLE THAT NO DATE, POSSIBLY ALL | yes | missing | no | no | yes | yes | yes | see document | |||||||||||
25 | LEO Pharma | $1.5bn | Picato gel, Xamiol, Daivobet/Dovobet/Taclonex | yes | no | no | no | yes | yes | No date given / Note this was problematic to score for our audit: the company give no date, but they stated to us that this is because their policy covers all trials and there is no start date. | yes | yes | yes | no / no timeline given, not all trials | yes | yes | yes | yes | UNCLEAR | yes | no | no | NO | yes | 1990 NOS / 1990 | yes | yes | NO | no | no | no | yes | NO | no | no | no | 1990 NOS / 1990 | they share CSRs publicly, it's only the appendices that are on request only. With the Position on Public Access to Clinical Trials Information, LEO Pharma commits to publishing Clinical Study Reports for all LEO Pharma sponsored clinical studies on our corporate website, once the product has been approved or the project has been terminated and the results have been published in the scientific literature, regardless of whether the results reflect positively or negatively upon our products. If publication in scientific literature is not pursued, the Clinical Study Report will be available within 12 months following the completion of the study. This commitment will be implemented from January 2014 for on-going and future clinical trials. Clinical Study Reports and Summaries for trials dating back to 1990 will be made available gradually from 2014 to 2017. Publishing Clinical Study Reports and Summaries from older trials is resource-intensive, and it will therefore take some time for all Clinical Study Reports dating back to 1990 to be made available. Where necessary, data will be removed in order to be able to maintain patient confidentiality and commercially confidential information. Appendices will only be available upon request. Clinical Study Reports for abandoned projects will be posted on our corporate website from 2014 and moving forward. | yes | 2000 NOS / 2000 | no | no | yes | yes | no | After the LEO Pharma Position on Public Access to Clinical Trials Information has come into effect, it will be possible for researchers to request access to anonymised patient level data from clinical trials sponsored by LEO Pharma for approved products dating back to 2000 when the Clinical Study Report is listed on our website. Starting in 2014, Clinical Study Reports will be made available on the LEO Pharma website once the medicine studied has been approved or terminated from development, and when publication of the results has been pursued. In the case that publication of the results of studies and terminated projects is not to be pursued, the data from such studies will be available within 12 months of study completion. Requests to access individual data from these trials will be evaluated by an independent Patient and Scientific Review Board. A review process is necessary to ensure that the request has a valid scientific rationale, is in the best interest of patients, and that granting access will not violate principles of informed consent or patient confidentiality. Application forms and instructions for how to request access to data will be available on our corporate website, www.leo-pharma.com, from January 1, 2014. THE PATIENT AND SCIENTIFIC REVIEW BOARD Requests for access to patient level data will be reviewed by a Patient and Scientific Review Board. The Board will comprise three independent researchers, and two seats on the Board are reserved for representatives from patient associations. The Patient and Scientific Review Board will accept or reject requests for data from clinical trials sponsored by LEO Pharma. Data must only be used for addressing a scientific question or conducting analysis in the interest of public health. The request for access to data must explain the aim of using the data and a description of the proposed analytical practice. In order not to compromise patient confidentiality, clinical trials data may not be used for any purpose outside of the boundaries of patients’ informed consent. The results of the research must be made publicly available. The Board will meet four times a year to review requests for access to data from clinical trials sponsored by LEO Pharma. Detailed information on the composition and procedures of the Board will be available in the Patient and Scientific Review Board Charter, which will be available on the LEO Pharma website January 1, 2014. | |||
26 | Lundbeck | $2.3bn | Cipralex/Lexapro, Onfi, Xenazine | yes | no | no | no | yes | yes | 2014 NOS / 2014 | yes / EXTREMELY THIN COMMITMENT: "Lundbeck registers clinical trial protocol information and discloses results of clinical trials, regardless of outcome, in a publicly accessible clinical trial registry, www.clinicaltrials.gov." Note they have removed all further details that were previously present in their 2015 policy, which may or may not be significant. | no | no | no | no | no | unclear | yes | yes | no | no / ph3 only. | no | no | unclear | 2014 NOS / 2014 | YES | YES | YES / LABORIOUS PROCESS LIKE IPD "The above described procedure will be in place only as long as no other mandatory procedures have been implemented by health authorities, e.g. the EMA POLICY/0070 regarding publication and access to clinical-trial data." | no | no | no | yes | yes | NO | NO | NO | "products approved in Europe and US after 1 January 2014." / 2012 | Presumably they mean CSRs when they say "clinical trial reports" in their brief document on transparency. However even this commitment is brief and contains caveats that are potentially catch all: "Lundbeck will share study protocols, anonymized patient data and redacted clinical trial reports from clinical trials with qualified scientific and medical researchers, as necessary for conducting legitimate research." Furthermore this is also only for "products approved in Europe and US after 1 January 2014". If this means a treatment must approved in both of two continents to be shared, then information would be inaccessible if approved and being used in only one continent. | yes | products approved after 2014 / 2012 | no | no | unclear | unclear / Very little information given. | no | see site | |||
27 | Medtronic | $28.8bn | Medical Devices | no | YES | NO | NO | NO | UNCLEAR | UNCLEAR | UNCLEAR | YES | NO | YES | NO | UNCLEAR | no | no | |||||||||||||||||||||||||||||||
28 | Menarini | $3.7bn | Lobivon/Nebilet/Nebilox, Enantyum, Adenuric | YES | no | no | no | YES | UNCLEAR | YES | YES | NO | NO | NO | NO | UNCLEAR | UNCLEAR | NO | NO | ||||||||||||||||||||||||||||||
29 | Merck & Co. | $40bn | Januvia, Zetia, Janumet | YES | no | no | no | YES | YES | started after 2007 / 2008 | YES | no / no timeline given | NO | no / 18 months, only phase 3 | NO | NO | YES | yes | yes | yes | NO / PH3 ONLY | no | no | YES / "Since 2007, Merck has registered, at trial initiation, all clinical trials in patients (Phases I-V) that the company sponsors and conducts worldwide on www.ClinicalTrials.gov. We also disclose results from all registered clinical trials of marketed products – regardless of outcome – on www.ClinicalTrials.gov." | started after 2007 / 2008 | yes | yes | yes / ONEROUS APPLICATION PROCESS AS PER IPD "for products or indications that have been approved by regulators in the US and EU." | no | no | no | yes | yes | no | no | no | started after 2007 "for products or indications that have been approved by regulators in the US and EU." / 2008 | If a request for a full CSR is approved, Merck will provide researchers the CSR in a redacted form that is consistent with the need to protect patient privacy and confidential commercial information.... "data will be made available for request approximately 18 months after clinical trial completion and acceptance of a primary results manuscript" | yes | started after 2007 "for products or indications that have been approved by regulators in the US and EU." / 2008 | no | no | yes | yes | UNCLEAR / "If you did not find a study on EngageZone you can send a request to: dataaccess@merck.com. Please include as much information about the study of interest as possible in your email, e.g. the study number, the NCT number from clinicaltrials.gov, and/or the citation to a study publication." | Merck may not have the legal authority because the product was co-developed with a partner or obtained from an external partner under a contract that does not permit the disclosure. It may be difficult to ensure protection of the privacy and confidentiality of research participants. For example, small trials (e.g., with less than 50 participants) or studies of rare diseases may have too few participants to prevent re-identification of individuals. The informed consent may not allow for data sharing.There may be substantial practical constraints to providing access to the data (for example, size and complexity of databases or resources required to retrieve data from repositories and redact personally identifiable information from relevant documents). see "Merck Procedure on Access to Clinical Trial Data" | |||
30 | Merck Serono | $17bn | Rebif, Erbitux, Gonal-F | yes | no | no | no | yes | yes | 2014 NOS / 2014 | yes | yes | no | no | no | no | YES | yes | yes | no | no | no | no | YES | 2014 / 2014 | yes | yes | yes / ONEROUS APPLICATION PROCESS AS PER IPD | no | no | no | yes | yes | no | no | no | products approved after 2014 IN BOTH EU AND US / 2012 | lots eg "In addition, data will not be shared with Merck Serono competitors." | yes | products approved IN BOTH EU AND US after 2014 / 2012 | no | no | YES | yes | no / "Data will not be shared for products and indications approved prior to January 1, 2014." | see doc | |||
31 | Novartis | $48.5bn | Gleevec, Gilenya, Lucentis | yes | no | no | no | yes | yes | 1999 NOS / 1999 | yes | yes | yes | no | yes | yes | yes | yes | yes | yes | no | yes | yes | yes | 2005 NOS / 2005 | yes | yes / ONEROUS APPLICATION AS PER IPD | yes / LABORIOUS PROCESS LIKE IPD | no | no | no | yes | yes | no | no | no | products approved after 2014 / 2012 | LOTS, AS PER IPD, ALSO PH4 EXCLUDED | yes | products approved after 2014 / 2012 | no | no | no | yes | yes | lengthy, see document | |||
32 | Novo Nordisk | $16.5bn | NovoRapid, Levemir, Victoza | yes | no | no | no | yes | yes | 2002 / 2002 | yes | yes / their commitment to within 12 months for summary results appears to be limited to compliance with law, ie geographically, but given that their commitment to a higher level of detail (sharing CSRs) does not include this caveat, that score is reasonably ported to here. | no | no | no | NO | yes | yes | yes | yes | no | no | NO | yes | 2005 NOS / 2005 | yes | yes | no | no | no | no | yes | no | no | no | no | trials completed after 2006 / 2005 | "The CSRs will be published without appendices and will be redacted to remove patient and site identifiable information. Further information is only to be removed from the CSRs if commercially confidential or if essential for protecting intellectual property rights. CSRs will be made available via www.novonordisk-trials.com. CSRs will gradually be made available. Moreover, summary reports from discontinued product development projects will be published within 12 months of the public announcement of project discontinuation." | yes | trials completed after 2001 / 2002 | no | no | YES | yes | no | lengthy, see document | |||
33 | Orion Pharma | $1bn | Precedex, Simdax, Stalevo | yes | no | no | no | yes | NO | missing | yes | no | no | no | no | no | no | NO | no | no | no | no | no | no | missing | no | yes | missing | no | no | unclear | NO | unclear | Very little information. Essentially says compliant with EFPIA-PhRMA principles | |||||||||||||||
34 | Otsuka | $11bn | Abilify, Samsca | yes | no | no | no | yes | no | missing | yes | no | no | no | yes | yes | yes | no | yes / Unusual policy, as commits to proactively post CSR summaries, and only share CSRs on request when they are unable to share IPD. | yes | no | no / "for all studies in patients included in marketing authorization submissions filed with US Food and Drug Administration, the European Medicines Agency and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan on or after January 1, 2014." | no | yes | yes | no | no | no | yes | "for all studies in patients included in marketing authorization submissions filed with US Food and Drug Administration, the European Medicines Agency and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan on or after January 1, 2014." / 2013 | yes | "Otsuka is committed to consider sharing patient-level data filed with the US and EU medicines regulatory agencies on or after January 1, 2014. Clinical studies will be listed on the website after regulatory approval(s)." / 2013 | no | no | yes | yes | |||||||||||||
35 | Pfizer | $53bn | Prevnar 13 Vaccine, Lyrica, Enbrel | yes | yes | yes | no | yes | yes | 2008 NOS Statement on Declaration of Helsinki dated 2008 is only current mention of a past date for registration. / 2008 | yes | yes | yes | no / policy is 18 months | unclear / This is a difficult edge case. Pfizer are inconsistent in two different documents in a way that may cast doubt on their apparent commitment to share summary results for all trials, but also leaves their commitment to sharing IPD unclear. On IPD sharing, in their online document (http://www.pfizer.com/research/research_clinical_trials/registration_disclosure_authorship saved as a word file) they say "Data will be available for studies for which Basic Results have been posted to ClinicalTrials.gov, dating back to 2007." There are no caveats in this document about approval or authorisation, or licensed or unlicensed uses, indeed none of those terms or concepts are mentioned in any context. However in a completely different (brief) document, "Clinical Trial Data Access - FAQs" a caveat is introduced: "Data are made available for trials of authorized medicines/indications, or terminated medicines, two years after clinical trial completion (defined as last subject last visit)." In their document "Clinical Trial Data Access" these two apparently contradictory statements appear side by side: " Pfizer will provide access to patient level data from clinical trials for which Basic Results are posted in the clinicaltrials.gov registry (dating back to September 2007). Data will be made available for patient level data from studies conducted for authorized (approved indications in the US and/or EU) or terminated medicines two years after clinical trial completion." It is not clear if: the apparent commitment to share summary results on all trials regardless of approval status is in fact limited by approval status of the drug and indication; or if there is an inconsistency in the description of IPD study availability; or if there is some third as yet unknown explanation. | unclear / as per unlicensed treatments | yes | yes | yes | yes | yes | unclear / as per prospective | unclear / as per prospective | yes | ongoing or INITIATED after 2007 / 2008 | yes | yes | yes | yes | yes | no | yes | yes | no / Pfizer are inconsistent in two different documents in a way that may cast doubt on their apparent commitment to share summary results for all trials, but also leaves their commitment to sharing IPD unclear. On IPD sharing, in their online document (http://www.pfizer.com/research/research_clinical_trials/registration_disclosure_authorship saved as a word file) they say "Data will be available for studies for which Basic Results have been posted to ClinicalTrials.gov, dating back to 2007." There are no caveats in this document about approval or authorisation, or licensed or unlicensed uses, indeed none of those terms or concepts are mentioned in any context. However in a completely different (brief) document, "Clinical Trial Data Access - FAQs" a caveat is introduced: "Data are made available for trials of authorized medicines/indications, or terminated medicines, two years after clinical trial completion (defined as last subject last visit)." In their document "Clinical Trial Data Access" these two apparently contradictory statements appear side by side: " Pfizer will provide access to patient level data from clinical trials for which Basic Results are posted in the clinicaltrials.gov registry (dating back to September 2007). Data will be made available for patient level data from studies conducted for authorized (approved indications in the US and/or EU) or terminated medicines two years after clinical trial completion." It is not clear if: the apparent commitment to share summary results on all trials regardless of approval status is in fact limited by approval status of the drug and indication; or if there is an inconsistency in the description of IPD study availability; or if there is some third as yet unknown explanation. | no / as per unlicensed treatments | no | ongoing or completed after 2007 / 2006 | yes | ongoing or completed after 2007 / 2006 | no / Pfizer are inconsistent in two different documents in a way that may cast doubt on their apparent commitment to share summary results for all trials, but also leaves their commitment to sharing IPD unclear. On IPD sharing, in their online document (http://www.pfizer.com/research/research_clinical_trials/registration_disclosure_authorship saved as a word file) they say "Data will be available for studies for which Basic Results have been posted to ClinicalTrials.gov, dating back to 2007." There are no caveats in this document about approval or authorisation, or licensed or unlicensed uses, indeed none of those terms or concepts are mentioned in any context. However in a completely different (brief) document, "Clinical Trial Data Access - FAQs" a caveat is introduced: "Data are made available for trials of authorized medicines/indications, or terminated medicines, two years after clinical trial completion (defined as last subject last visit)." In their document "Clinical Trial Data Access" these two apparently contradictory statements appear side by side: " Pfizer will provide access to patient level data from clinical trials for which Basic Results are posted in the clinicaltrials.gov registry (dating back to September 2007). Data will be made available for patient level data from studies conducted for authorized (approved indications in the US and/or EU) or terminated medicines two years after clinical trial completion." It is not clear if: the apparent commitment to share summary results on all trials regardless of approval status is in fact limited by approval status of the drug and indication; or if there is an inconsistency in the description of IPD study availability; or if there is some third as yet unknown explanation. | no / as per unlicensed treatments | yes | yes | NO | Caution here: others have cited problems with consent forms etc, while Pfizer have not cited any further exclusions, it is likely that they will feel restricted by the same issues as other companies even if they have not explicitly said so. | ||||
36 | Purdue Pharma | $3bn | Oxyxcontin, MS contin | no | no | no | yes | missing | no | no | no | yes | no | This process will be limited to Purdue Pharma L.P.’s (Purdue) clinical trials involving medicines and indications approved, or those officially discontinued by Purdue, in the United States. The provision of such data will only apply to phase 2 and 3 patient-level clinical trial data, study-level clinical trial data, and protocols in accordance with stipulations in the informed consent (ICF) signed at the time of giving consent. All patient level data will be made anonymous. If the data cannot be made anonymous, they shall not be provided. Scientific Review Board: The Purdue Scientific Review Board (SRB) will consist of members of Purdue’s Research and Development, Medical Services, Law and Compliance departments and two clinical researchers who are not employees of Purdue. Requests for data will be evaluated and the requester will be notified of the SRB’s decision. Request Process: Any requests for clinical data should be in conformance with PhRMA’s Principles for Responsible Clinical Trial Data Sharing. The request will be forwarded to Purdue’s Medical Services Department who will call a meeting of the SRB within 30 days to review the request. Requests will only be considered if the research proposal contains the following (at a minimum): • Reasons and rationale supporting the legitimacy of the research; • Qualifications of the requestor; • A description of the data being requested, including the hypothesis to be tested; • The rationale for the proposed research; • The analysis plan; • A publication plan; • Qualifications and experience of the proposed research team; • A description of any potential conflicts of interest; including potential competitive use of the data; and • The source of any research funding. In addition, the requestor must agree to the following: • Any research conducted using the data obtained from this request will be submitted for publication according to an SRB approved publication plan; • The data obtained shall not be transferred or shared with any party not identified in this request; • There shall be no use of the data for purposes not contained in the request; and • The requestor and anyone involved in the research must agree that any patient-level data that is shared will be anonymized to protect personally identifiable information and that requestor or anyone involved in the research will not attempt to defeat this de-identification. | |||||||||||||||||||||||||||||||||||
37 | Roche | $50bn | Rituxan, Avastin, Herceptin | unclear / This is hard to code. Roche's policy PDF "Roche Global Policy On Sharing Of Clinical Trials Data" does not appear to make a clear statement about registration. It has a section header that mentions it, but the text only refers to "summary reports": "Clinical Trial Registration and Posting of Results on Public Web Sites Roche is committed to providing comprehensive information on clinical trials conducted by Roche to healthcare professionals and to the public, regardless of the outcome of these trials. Roche posts summary reports on ClinicalTrials.gov (CT.gov) for all Roche-sponsored Phase I clinical trials in patients, all Phase II–IV interventional and observational clinical trials, and all Roche-sponsored interventional trials that use diagnostic products." There is another mention related to registration in a second Roche policy document titled "Roche Global Policy on Sharing of Clinical Study Information" that reads: "We publish information from our protocols and clinical study results information on clinical trial registries. Clinical trial registries are an important source of information for physicians and patients because they help them to know if a study is recruiting, ongoing or is completed. Clinical trial registries also help physicians and patients access results once available." Again we do not view that as a clear commitment to register all trials. In addition, on the webpage "Our Commitment to Data Sharing", a third policy document containing information about Roche's commitments, (http://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm ) they say: "Roche's clinical trials registry was launched in 2004 with the aim of ensuring researchers and other interested parties could access protocols and also the results of our Phase I to IV clinical studies " and "Roche is committed to sharing data from clinical trials and has registered and posted summary reports for trials involving patients on appropriate clinical registries since 2005." Collectively this may mean that Roche register all trials, since 2005, but this is not made clear. This lack of clarity is made more problematic by the apparent conflict with the 2013 start date (see relevant field) for sharing all summary results: i.e., one could accept this vaguely worded commitment for 2005 as covering registration of all trials from 2005, but that would then naturally imply accepting that all summary results are shared from 2005 as well; however the parts of the Roche policy document (or rather, documents) that discuss results policy appear to suggest 2013 as the start date for all trials to share summary results. Therefore, although it is an edge case, this can only be realistically coded as unclear on registration, because it lacks a clear commitment to "all", and the most permissive/generous reading of the text produces a result that is inconsistent with other aspect of Roche's policies. | no | no | no | yes | unclear / This is hard to code. Roche's policy PDF "Roche Global Policy On Sharing Of Clinical Trials Data" does not appear to make a clear statement about registration. It has a section header that mentions it, but the text only refers to "summary reports": "Clinical Trial Registration and Posting of Results on Public Web Sites Roche is committed to providing comprehensive information on clinical trials conducted by Roche to healthcare professionals and to the public, regardless of the outcome of these trials. Roche posts summary reports on ClinicalTrials.gov (CT.gov) for all Roche-sponsored Phase I clinical trials in patients, all Phase II–IV interventional and observational clinical trials, and all Roche-sponsored interventional trials that use diagnostic products.". In addition, on the webpage "Our Commitment to Data Sharing" (http://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm ) they say: "Roche's clinical trials registry was launched in 2004 with the aim of ensuring researchers and other interested parties could access protocols and also the results of our Phase I to IV clinical studies " and "Roche is committed to sharing data from clinical trials and has registered and posted summary reports for trials involving patients on appropriate clinical registries since 2005." Collectively this may mean that Roche register all trials, since 2005, but this is not made clear. | 2005 NOS This is hard to code. Roche's policy PDF "Roche Global Policy On Sharing Of Clinical Trials Data" does not appear to make a clear statement about registration. It has a section header that mentions it, but the text only refers to "summary reports": "Clinical Trial Registration and Posting of Results on Public Web Sites Roche is committed to providing comprehensive information on clinical trials conducted by Roche to healthcare professionals and to the public, regardless of the outcome of these trials. Roche posts summary reports on ClinicalTrials.gov (CT.gov) for all Roche-sponsored Phase I clinical trials in patients, all Phase II–IV interventional and observational clinical trials, and all Roche-sponsored interventional trials that use diagnostic products.". In addition, on the webpage "Our Commitment to Data Sharing" (http://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm ) they say: "Roche's clinical trials registry was launched in 2004 with the aim of ensuring researchers and other interested parties could access protocols and also the results of our Phase I to IV clinical studies " and "Roche is committed to sharing data from clinical trials and has registered and posted summary reports for trials involving patients on appropriate clinical registries since 2005." Collectively this may mean that Roche register all trials, since 2005, but this is not made clear. / 2005 | yes / "Roche is committed to providing comprehensive information on clinical trials conducted by Roche to healthcare professionals and to the public, regardless of the outcome of these trials. Roche posts summary reports on ClinicalTrials.gov (CT.gov) for all Roche-sponsored Phase I clinical trials in patients, all Phase II–IV interventional and observational clinical trials, and all Roche-sponsored interventional trials that use diagnostic products." | no / No timelines "Roche posts summary reports on ClinicalTrials.gov (CT.gov) for all Roche-sponsored Phase I clinical trials in patients, all Phase II–IV interventional and observational clinical trials, and all Roche-sponsored interventional trials that use diagnostic products." | no | NO | yes / "Roche posts summary reports on ClinicalTrials.gov (CT.gov) for all Roche-sponsored Phase I clinical trials in patients, all Phase II–IV interventional and observational clinical trials, and all Roche-sponsored interventional trials that use diagnostic products." | yes | yes | yes | yes / "Roche's clinical trials registry was launched in 2004 with the aim of ensuring researchers and other interested parties could access protocols and also the results of our Phase I to IV clinical studies. We established this site because the independent platforms available at the time did not enable us to publish all of the details we wished to share. Since this time the regulations governing existing independent registries have changed and we are now able to share all relevant protocols and information on these platforms. As such, we are working to transition the information contained on the Roche Clinical Trials Registry to the NIH ClinicalTrials.gov and the EMA EUdraCT platforms." | no | yes / "Regardless of outcome, Roche commits to submit the primary clinical study results for publication in a peer- reviewed journal in a timely, objective and clinically meaningful manner." | yes / "Roche posts summary reports on ClinicalTrials.gov (CT.gov) for all Roche-sponsored Phase I clinical trials in patients, all Phase II–IV interventional and observational clinical trials, and all Roche-sponsored interventional trials that use diagnostic products." | yes / "Roche posts summary reports on ClinicalTrials.gov (CT.gov) for all Roche-sponsored Phase I clinical trials in patients, all Phase II–IV interventional and observational clinical trials, and all Roche-sponsored interventional trials that use diagnostic products." | yes | 2013 NOS "The policy set forth in this document was adopted on 17 April 2013 and entered into force on 1 June 2013." Note previous years' policies had other dates (e.g. 2002) but the current document gives no insight on dates beyond 2013. In addition: "This policy applies to Clinical Study Reports and summary reports that have been used for regulatory purposes since 1 January 1999. It will also apply to reports that have not been used for regulatory purposes and are finalized on or after 1 January 2013." 1999 commitment covers limited set / 2013 | yes | yes | yes / Simple request process and share with the public, i.e. no CVs or project description. "Firstly, we will make the reports that we write on the clinical trial (called Clinical study reports or CSRs, periodic safety reports, and clinical trial summary reports) available to members of the public on request." | yes / depends on date but scoring most complete commitment 2013 "Roche established the processes we use today for managing Clinical Study Reports and the data from clinical trials in 1999. We will provide data from trials and Clinical Study Reports from studies conducted as far back as 1999 if those studies have been used for regulatory purposes. In certain circumstances we may be able to provide CSRs or other reports from trials conducted earlier. For trials which were not used for regulatory purposes, we will provide CSRs from 1st January 2013." However note this is discrepant with their Clinical Study Data Request page which reads: "All phase 2 and 3 clinical studies or phase 4 studies that were used as part of a regulatory approval or where the product was terminated from development (all indications) with a first patient enrolled as of 1 January 1999 onwards. Roche is in the process of compiling a list of studies in scope. Roche will regularly update this list to add studies going back to January 1999. In the event that you cannot see a specific study in the Roche list, an Enquiry Form can be submitted to confirm the availability of the specific study" and includes a commitment to share CSRs. However since CSR applications are open to all, including the public, not just academics requesting through CSDR, then for CSRs we have coded the commitment in their standalone policy document. | yes / depends on date but scoring most complete commitment 2013 "Roche established the processes we use today for managing Clinical Study Reports and the data from clinical trials in 1999. We will provide data from trials and Clinical Study Reports from studies conducted as far back as 1999 if those studies have been used for regulatory purposes. In certain circumstances we may be able to provide CSRs or other reports from trials conducted earlier. For trials which were not used for regulatory purposes, we will provide CSRs from 1st January 2013. " | no | yes | yes | yes / depends on date but scoring most complete commitment 2013 "Roche established the processes we use today for managing Clinical Study Reports and the data from clinical trials in 1999. We will provide data from trials and Clinical Study Reports from studies conducted as far back as 1999 if those studies have been used for regulatory purposes. In certain circumstances we may be able to provide CSRs or other reports from trials conducted earlier. For trials which were not used for regulatory purposes, we will provide CSRs from 1st January 2013." | yes / depends on date but scoring most complete commitment 2013 "Roche established the processes we use today for managing Clinical Study Reports and the data from clinical trials in 1999. We will provide data from trials and Clinical Study Reports from studies conducted as far back as 1999 if those studies have been used for regulatory purposes. In certain circumstances we may be able to provide CSRs or other reports from trials conducted earlier. For trials which were not used for regulatory purposes, we will provide CSRs from 1st January 2013." | no | Depends on date but scoring most complete commitment 2013 "Roche established the processes we use today for managing Clinical Study Reports and the data from clinical trials in 1999. We will provide data from trials and Clinical Study Reports from studies conducted as far back as 1999 if those studies have been used for regulatory purposes. In certain circumstances we may be able to provide CSRs or other reports from trials conducted earlier. For trials which were not used for regulatory purposes, we will provide CSRs from 1st January 2013." / 2013 | yes | initiated since 1999 / 2000 | no | no | no / "Exceptions... Phase 4 clinical studies conducted for non-registrational purposes or local affiliate studies." | yes | yes | All phase 2 and 3 clinical studies or phase 4 studies that were used as part of a regulatory approval or where the product was terminated from development (all indications) with a first patient enrolled as of 1 January 1999 onwards. Roche is in the process of compiling a list of studies in scope. Roche will regularly update this list to add studies going back to January 1999. Clinical studies with a sample size of less than 50 patients or in rare diseases. This is because anonymisation of these data is more difficult to achieve. For these studies Roche will assess the feasibility of anonymisation as part of the review of enquiries. Phase 4 clinical studies conducted for non-registrational purposes or local affiliate studies. After the medicine studied has been approved by regulators for the indication in both the US and EU or terminated from development (all indications). 18 months after completion of the study report (to enable a publication to be submitted). When patients agreed to take part in Roche clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease Roche were researching. Further research must therefore study the medicine or disease that was researched in the original studies. For future studies (2014 onwards) patients will be asked to give permission for broader research so other research may be possible with data from these studies. A condition of providing the data is that the external requester seeks publication of their research results. Roche are to be provided with a copy of the manuscript after journal submission for information. Roche may chose to provide the requester with comments on the document as a courtesy, but the external requester is not obliged to incorporate any feedback resulting from this review. | ||||
38 | Sanofi | $36.5bn | Lantis, Plavix, Lovenox | yes | no | no | no | yes | unclear | unclear | yes | no / no timeline given | no | no | no | NO | yes | unclear | UNCLEAR | yes | yes | yes / LABORIOUS PROCESS LIKE IPD | no | no | no | yes | yes | no | no | no | treatments approved since 2014 / 2012 | "Sanofi will make clinical trial data and full CSRs available from studies sponsored by Sanofi group of companies1, except Sanofi Pasteur, submitted to the US and EU regulatory agencies and where the product will be approved by both agencies on or after January 1, 2014. We will also make available trial data and full CSRs from vaccine studies sponsored by Sanofi Pasteur, submitted either to the US or EU regulatory agencies and where the product will be approved by either agency on or after January 1, 2014. For all trials conducted by the Sanofi group of companies, the requested trials must also have been accepted for publication." | yes | treatments approved since 2014 / 2012 | no | no | no | yes | no | extensive, see site | |||||||||
39 | Servier | $4.25bn | Aceon, Diamicron, Vastarel | yes | no | no | no | yes | YES | 2004 / 2004 | no | no | no | ||||||||||||||||||||||||||||||||||||
40 | Sigma-Tau | N/A | N/A | No / no policy in folder. | |||||||||||||||||||||||||||||||||||||||||||||
41 | Takeda | $16bn | Velcade, Protonix, Entyvio | yes | no | no | no | yes | yes | 2002 NOS / 2002 | yes | yes | yes | no / no timeline given | yes | yes | yes | yes | no | yes | no | no | no | yes | medicines approved since 2005 / 2003 | yes | yes | yes / LABORIOUS PROCESS LIKE IPD | no | NO | no | yes | yes | no | no | no | medicines approved since 2005 / 2003 | "Clinical trials will be listed for Takeda-sponsored Phase 1-4 interventional trials supporting approved products as described below. Commercially available new medicines or vaccine products that have received marketing approval for a given indication or formulation since 01 January 2005 as follows: • US and EU approval. • US or EU approval (when regulatory submissions in both regions are not planned). • Japan approval (when US or EU regulatory submissions are not planned). Clinical trials will also be listed for Takeda-sponsored Phase 1-4 interventional trials relating to terminated compounds. Terminated compounds are unapproved medicines or vaccines for which clinical development is completely terminated on or after 01 January 2014. Takeda will only share clinical data when it is feasible to anonymize the data without compromising the privacy of trial participants. This may affect small clinical trials of rare diseases or trials with a very small number of patients, which will be reviewed on a case-by-case basis. Prematurely discontinued trials that have insufficient enrollment/exposure to warrant analysis may not be listed. Interim data from completed or ongoing clinical trials will generally not be shared. In rare cases, information may be restricted by Takeda in order to protect commercially confidential information (CCI) and intellectual property (IP) rights. Takeda Consumer Healthcare products will not be subject to data sharing. Clinical trials will be eligible for listing once the above criteria are met and the primary manuscript has been accepted for publication. For approved products, clinical trials supporting subsequent local approvals (including registration trials that specifically support approval in Japan), new indications, combination products, or major formulation changes will be eligible for listing after the corresponding regulatory approvals have been achieved. Takeda is in the process of listing trials in scope. Takeda will regularly update this list to add trials meeting the criteria. For in-scope trials that are not yet listed, Takeda will assess the feasibility of data provision as part of the review of enquiries. ..... Documents will be redacted to protect personal data of trial participants, trial personnel, and Takeda employees (consistent with applicable privacy laws/regulations), and to protect Takeda’s CCI and IP rights when required. Takeda will not share case narratives, documentation for event adjudication, imaging data (e.g., x-rays, MRI scans, etc.), genetic data, or other information that Takeda considers may compromise trial participant privacy." | yes | medicines approved since 2005 / 2003 | no | no | yes | yes | no | Clinical trials will be listed for Takeda-sponsored Phase 1-4 interventional trials supporting approved products as described below. Commercially available new medicines or vaccine products that have received marketing approval for a given indication or formulation since 01 January 2005 as follows: • US and EU approval. • US or EU approval (when regulatory submissions in both regions are not planned). • Japan approval (when US or EU regulatory submissions are not planned). Clinical trials will also be listed for Takeda-sponsored Phase 1-4 interventional trials relating to terminated compounds. Terminated compounds are unapproved medicines or vaccines for which clinical development is completely terminated on or after 01 January 2014. Takeda will only share clinical data when it is feasible to anonymize the data without compromising the privacy of trial participants. This may affect small clinical trials of rare diseases or trials with a very small number of patients, which will be reviewed on a case-by-case basis. Prematurely discontinued trials that have insufficient enrollment/exposure to warrant analysis may not be listed. Interim data from completed or ongoing clinical trials will generally not be shared. In rare cases, information may be restricted by Takeda in order to protect commercially confidential information (CCI) and intellectual property (IP) rights. Takeda Consumer Healthcare products will not be subject to data sharing. Clinical trials will be eligible for listing once the above criteria are met and the primary manuscript has been accepted for publication. For approved products, clinical trials supporting subsequent local approvals (including registration trials that specifically support approval in Japan), new indications, combination products, or major formulation changes will be eligible for listing after the corresponding regulatory approvals have been achieved. Takeda is in the process of listing trials in scope. Takeda will regularly update this list to add trials meeting the criteria. For in-scope trials that are not yet listed, Takeda will assess the feasibility of data provision as part of the review of enquiries. Data sharing is constrained by the requirements of the informed consent obtained at the time each clinical trial was conducted. In general, new research conducted on shared data must assess the specific medicine, disease or objective that was assessed in the original trial. For Takeda clinical trials initiated after this policy is enacted, patients will be asked to give permission for broader research beyond the original trial, so that other research may be possible with these data. Where data is subject to legal, contractual, or consent provisions that restrict transfer to third parties, data access may be precluded. Other practical constraints to providing access to the data may also preclude sharing. Where available, the following anonymized patient level data and/or supporting documents are provided for each clinical trial. Information/documents will not be translated and in rare instances practical issues relating to redaction and availability of non-English documents may limit sharing. Raw dataset. This is the data collected for each patient in the clinical trial. Analysis-ready dataset. This is the dataset used for Takeda’s analysis. Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical trial. Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset. Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) Takeda used for the trial. Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats. Clinical study report. This is the report of efficacy and safety data from the trial. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient level data are generally not included as these data are provided in the datasets Takeda provides. Documents will be redacted to protect personal data of trial participants, trial personnel, and Takeda employees (consistent with applicable privacy laws/regulations), and to protect Takeda’s CCI and IP rights when required. Takeda will not share case narratives, documentation for event adjudication, imaging data (e.g., x-rays, MRI scans, etc.), genetic data, or other information that Takeda considers may compromise trial participant privacy. | |||
42 | UCB | $4.5bn | Cimzia, Vimpat, Keppra | yes | no | no | no | yes | yes | trials started after 2004 / 2005 | yes | no / no timeline given | no / no timeline given | no / no timeline given | no | unclear | yes | yes | yes | yes | yes | no | unclear | yes | trials started after 2004 / 2005 | yes | yes | yes / LABORIOUS PROCESS LIKE IPD | no | no | yes | yes | unclear | no | NO | yes | trials submitted to regulators after 2014 / 2013 | "Following approval of a new medicine or new indication for an approved medicine, UCB pledges to make available the synopses of Clinical Study Reports (CSRs) for clinical studies in patients submitted to regulatory authorities on or after January 1, 2014. The synopses of CSRs will be redacted to protect patient privacy, publication rights, intellectual property, and trade secret and confidential commercial information." | yes | missing | no | NO | UNCLEAR | yes | yes | "This listing reflects the clinical study data provided by UCB on the Multi-Sponsor Analysis Hosting System and that are being prepared for data sharing. This list includes clinical studies that were considered ‘pivotal studies’ for purposes of regulatory approval of certolizumab pegol, lacosamide, rotigotine and levetiracetam. Requests for access to additional clinical study data will be considered on a case-by-case basis. Clinical studies of rare diseases, small number of subjects or small number of investigative sites; where there is reasonable likelihood that the individual participants could be re-identified.. Access to data is determined by the Independent Review Panel based on the scientific merit of the research proposal. In exceptional circumstances, access to data may be declined by the sponsor, for example, where there is a potential conflict of interest or an actual or potential competitive risk. Studies are considered for inclusion after the medicine studied has been approved by the regulatory authorities (first approval in the respective indication) or terminated from development (all indications) and the primary manuscript describing the results has been accepted for publication. When patients agreed to take part in UCB clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease UCB were researching. Further research must therefore study the medicine or disease that was researched in the original studies. For studies starting January 2014, patients will be asked if they agree to give permission for data usage in analyses by UCB or outside academic researchers to answer additional scientific questions related to the study drug/condition. UCB will take appropriate measures to protect this information and will only use and share coded data for this additional research. A condition of providing the data to an external researcher is that the external researcher seeks publication of his/her research results in a peer-reviewed journal. UCB is to be provided with a copy of the manuscript for review prior to journal submission to prevent the unintended disclosure of UCB’s confidential information. UCB will not seek to influence the content of a publication or the opinion of the external researcher through the review of the publication. UCB supports publications that contain scientifically and/or clinically meaningful results. Other than identification of UCB’s confidential information, the final decision whether to accept any comments made by UCB remains with the external researcher. Where available, the following anonymised patient level data and information is provided in English only for each clinical study. Raw dataset. This is the data collected for each patient in the clinical study. Analysis-ready dataset. This is the dataset used for UCB’s analysis. Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study. Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset. Statistical analysis plan with any amendments. This describes methods of analysis and procedures for data handling UCB used for the study. Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats. Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient level data, confidential information, or investigator specific information are not included. To protect research participants’ privacy and confidentiality, case narratives are not included. The clinical study report has been redacted by UCB with respect to the commercially confidential information and anonymised to protect patient privacy. YES Whether the studies have been published or accepted for publication and whether the studies researched terminated or authorised medicines (for approved uses). Whether UCB are able to provide the requested data. For example, the majority of non-interventional (or observational) studies use data from third party databases under license agreements which prevent UCB from providing access to the data. Researchers can access data directly from these third party databases under similar agreements. Whether UCB has the legal authority to provide the data. For example, UCB may not have the legal authority because the medicine has been out-licensed to another company. Whether UCB considers it feasible to anonymise the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve. Whether UCB considers that there are any practical or technical constraints on providing access to the data. For example, imaging data will not be provided. Whether it is feasible for UCB to retrieve data and documents from repositories and archives, anonymize data, and redact personally identifiable information from relevant documents. In some cases, particularly for older studies, it may not be feasible to adequately anonymise datasets, and UCB may turn down requests on this basis. " | |||
43 | Valeant | $9.7bn | Xifaxan 550, Jublia, Wellbutrin XL | no / no policy in folder. | |||||||||||||||||||||||||||||||||||||||||||||
44 | ViiV Healthcare | N/A | Vaccines | UNCLEAR / No clear commitment. Only "The ViiV Healthcare Clinical Study Register provides an easily accessible repository of data from ViiV Healthcare-Sponsored Clinical Studies, supplementing communication in journals, at scientific meetings, in letters to healthcare professionals, and in approved prescribing information. The register includes: • protocol summaries for ongoing studies (a brief description of what is being researched and what the study is designed to discover) " | NO | UNCLEAR / Only says: "The ViiV Healthcare Clinical Study Register provides an easily accessible repository of data from ViiV Healthcare-Sponsored Clinical Studies, supplementing communication in journals, at scientific meetings, in letters to healthcare professionals, and in approved prescribing information. The register includes: • protocol summaries for ongoing studies (a brief description of what is being researched and what the study is designed to discover) • results from completed clinical studies on compounds that are both investigational and approved medicines." | no | no / no timeline given | no | yes / Unclear if they do share results of all trials, however if they do then "results from completed clinical studies on compounds that are both investigational and approved medicines" | yes / Unclear if they do share results of all trials, however if they do then "results from completed clinical studies on compounds that are both investigational and approved medicines" | UNCLEAR | UNCLEAR / Only says: "The ViiV Healthcare Clinical Study Register provides an easily accessible repository of data from ViiV Healthcare-Sponsored Clinical Studies, supplementing communication in journals, at scientific meetings, in letters to healthcare professionals, and in approved prescribing information. The register includes: • protocol summaries for ongoing studies (a brief description of what is being researched and what the study is designed to discover) • results from completed clinical studies on compounds that are both investigational and approved medicines." | NO | UNCLEAR / Only says: "The ViiV Healthcare Clinical Study Register provides an easily accessible repository of data from ViiV Healthcare-Sponsored Clinical Studies, supplementing communication in journals, at scientific meetings, in letters to healthcare professionals, and in approved prescribing information. The register includes: • protocol summaries for ongoing studies (a brief description of what is being researched and what the study is designed to discover) • results from completed clinical studies on compounds that are both investigational and approved medicines." | no | yes / Unclear if they do share results of all trials, however if they do then "results from completed clinical studies on compounds that are both investigational and approved medicines" | yes / Unclear if they do share results of all trials, however if they do then "results from completed clinical studies on compounds that are both investigational and approved medicines" | UNCLEAR | missing | yes | yes | yes / LABORIOUS PROCESS LIKE IPD | NO | NO | no | yes | yes | NO | NO | no | missing | "After the medicine studied has been approved by regulators (first approval) or terminated from development and the study has been accepted for publication." | yes | missing | NO | NO | yes | yes | yes | "After the medicine studied has been approved by regulators (first approval) or terminated from development and the study has been accepted for publication. When patients agreed to take part in ViiV Healthcare clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease ViiV Healthcare (or its parent companies) were researching. Further research must therefore study the medicine or disease that was researched in the original studies. For studies ViiV Healthcare conduct from 2014, patients will be asked to give permission for broader research so other research may be possible with data from these studies. " | ||||||||
45 | EFPIA/PhRMA "Sharing" 2013 | NO | NO | Yes / The document states that full CSRs may be applied for under the same terms as IPD sharing "as necessary for conducting legitimate research". They make no commitment about whcih trials are included, from what time period, for what territories, and with what exemptions on the basis of phase, or approval status for products, or approval status for indications. | Yes / Caution. The document states that full CSRs may be applied for under the same terms as IPD sharing "as necessary for conducting legitimate research". They make no commitment about whcih trials are included, from what time period, for what territories, and with what exemptions on the basis of phase, or approval status for products, or approval status for indications. | yes / LABORIOUS PROCESS LIKE IPD | no | no | no | yes | yes / LABORIOUS PROCESS LIKE IPD | no | no | no | 2014 NOS | Yes / IPD will be shared "as necessary for conducting legitimate research". Caution. They make no commitment about whcih trials are included, from what time period, for what territories, and with what exemptions on the basis of phase, or approval status for products, or approval status for indications. | 2014 nos | no | no | no | no | see site | |||||||||||||||||||||||||||
46 | PhRMA "Conduct" 2014 | YES | NO | NO | NO | YES | NO | YES | UNCLEAR / Principle 4 states that submission and posting of clinical trial results should be “timely.” What does “timely” mean? "Generally for approved products, companies submit applicable clinical trial results to a government database by the latter of 12 months after the trial ends or within 30 days after approval of the drug." | UNCLEAR | NO | NO | NO | YES | NO | NO | NO | ||||||||||||||||||||||||||||||||
47 | PhRMA et al 2005 | yes | no | no | no | yes | yes | initiated after 2005 / 2006 | yes | no | no / Not a firm commitment, and caveats. "The results generally should be posted within one year... unless..." | no | no | no | unclear | yes | no | yes | no | no | no | unclear | initiated after 2005 / 2006 | no | no | ||||||||||||||||||||||||
48 | PhRMA et al 2009 | yes | no | no | no | yes | yes | initiated after 2009 / 2010 | yes | no | no / Note caveats. "The results should be posted no later than one year after the medicinal product is first approved and commercially available in any country. For trials completed after this initial approval, results should be posted no later than one year after trial completion. ***These schedules would be subject to adjustment to comply with national laws or regulations or to avoid compromising publication in a peer-reviewed medical journal***." | no | no | no | unclear | yes | no | yes | no | no | no | unclear | initiated after 2009 / 2010 | no | no | ||||||||||||||||||||||||
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