Common Practices for Subgroup Identification and Analysis

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This is the Data Collection Tool for Assessing Common Practices in Biomarker and Subgroup Analysis and Identification in Pharmaceutical Industry.

This survey is conducted by the Subgroup Analysis Working Group sponsored by the industry group QSPI (Quantitative Sciences in the Pharmaceutical Industry) operating as part of the Society for Clinical Trials and is intended solely for collecting anonymous responses with the purpose of identifying common trends in how subgroup analyses (SA) are conducted within pharmaceutical industry. The survey will assess the current state of subgroup analysis/identification activities in industry in order to help integrate good practices and create a unifying framework for SA across industry.

No information directly identifying companies or respondents will be collected

Where do you work? *

Please provide some information about your company

Big Pharma

Small/Medium company

Biotech

CRO

Independent consulting

Other:

What department do you work at? *

Please provide some information about your functional area

Clinical statistics

Non-Clinical statistics

PK/PD modeling

Statistical modeling and simulation

Medical Affairs

Other:

What types of Subgroup Analysis (SA) are routinely done in your company? *

Please read carefully the explanation for different types (or domains) of SA provided below and choose as many as you use.

SA1 - Confirmatory SA based on a (small) number of pre-specified subgroups (e.g. identified in earlier studies), typically employing strict control of the type I error

SA2 - Exploratory SA specified at the protocol development stage (eg., hypothesis generating subgroups)

SA3 - Post-hoc SA to address some questions that become evident after main study results are derived (e.g. a response to regulatory inquiry, a safety issue, post-marketing activities in Phase IV, treatment heterogeneity in multiregional studies)

SA4 - Biomarker & subgroup discovery from a large pool of candidate biomarkers (employing complex data mining/machine learning algorithms), often with the idea of informing future designs

Required

What type of Subgroup Analysis you are most familiar with ? *

Please choose only one type at a time from the 4 types described above because the subsequent questions will apply only to the SA type you have selected for this question. If you are familiar with more than 1 type, please complete a separate survey for each of the SA type(s).

SA1 - Confirmatory SA

SA2 - Exploratory SA

SA3 - Post-hoc SA

SA4 - Biomarker/Subgroup discovery

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