The Playbook in action:
Case Study Library
See how organizations are using The Playbook resources to solve real-world problems within their organizations. (Alphabetical by organization name)
(Last update October 4, 2021)
Want to include your case study?
Submit details here.
The Playbook is a great "toolbox" when working with a diverse team. It allows for a clear level set on current situations, understand client needs, expand on education, and use technology successfully in a clinical trial.”
The Problem
We often start with determining how a problem/situation should be described, how it's resolved, and how to better understand the benefit of digital measures for specific roles using the correct methods. Improving the dialogue between technology providers and pharma companies is paramount to supporting more digital trials.
The Resources
The Business Developers and Operations use tools such as the "Dossiers" to scope their client conversations to address the biggest needs for their role.
The Impact
✓ Project success, Greater patient centricity ✓ Clear communication internally - execs ✓ Clear communication - external partners ✓ Operational efficiencies and/or faster decision making ✓ Refined / Improved strategy
ActiGraph provides sensors, services, and software for the use of digital endpoints in clinical research and trials.
The Playbook provided a comprehensive and well-structured information resource that helps our organization to build a common language and establish a common knowledge baseline for different functions to be able to engage in a more constructive and streamlined fashion.”
The Challenge
Several cross-functional working groups have been established within Bayer to establish processes and share knowledge about the use and development of novel digital measures and DCT components in our clinical development programs. We were trying to address several challenges:
The Resource
The Playbook in its entirety provided a comprehensive and well-structured information resource that helps us to build a common vocabulary and establish a common knowledge baseline for different functions to be able to engage in a more constructive and streamlined fashion. Several functions are able to find valuable information in The Playbook slides and either dive deep into aspects directly related to their work or to get a general understanding of aspects related to the work of other functions.
The Impact
✓ Operational efficiency ✓ Clear communication with internal and external stakeholders ✓ Team education & cohesion ✓ Better alignment ✓ Greater patient-centricity ✓ Resulting in enhanced strategy
Bayer is a Life Science company with a more than 150-year history and core competencies in the areas of healthcare and agriculture. With our innovative products, we are contributing to finding solutions to some of the major challenges of our time.
The Playbook is driving the industry towards a consistent language and framework for remote monitoring that leads to more productive conversations and empowered decision making.”
The Problem
All too often, organizations want to jump immediately into the technology selection and want HumanFirst to recommend, "XZY is the best heart rate monitor."�
However, we found that selecting technology too soon results in circular conversations and there is no "best heart rate monitor" - it depends on the use case.
The Resource
The Playbook concretely distills language for WHY jumping into technology too soon creates problems. Citing The Playbook as an industry standard gives credibility to the process of starting with meaningful measurement and provides a framework for technology evaluations that a customer can adopt and adjust for their unique needs.
The Impact
✓ Operational efficiency ✓ Clear communication with pharma partners ✓ Team education & cohesion
HumanFirst serves those pioneering decentralized clinical trials and virtual care. Twenty-two of the top 25 pharmaceutical companies use HumanFirst's workflow and infrastructure solutions to evaluate and deploy connected sensor technologies.
We are extremely proud of our involvement in the development of The Playbook, and wanted to promote The Playbook while demonstrating how our work exemplifies the principles it sets out.”
The Problem
At Koneksa, we are constantly seeking new and better ways to educate trial sponsors - our current clients, our potential clients, and the industry at large - on the potential benefits that digital clinical trials hold for them.
The Resource
Koneksa have developed our “Playbook Digest”, a series of short whitepapers in which we summarize a relevant portion of The Playbook and relate it to an illustrative example of our recent work (see recent examples on oncology and pulse oximetry).
We used series to help increase awareness and understanding in the industry. It's great to have documentation of the collective wisdom of all of the thought leaders in this space.
The Impact
Koneksa is a leading patient-centric digital biomarker company for the pharmaceutical and biotechnology industries that develops end-to-end solutions for remotely collected clinical data. Koneksa supports agile decision-making in drug development and market strategy. By delivering integrated solutions for efficient trial designs that produce more meaningful data, Koneksa aims to revolutionize effect detection in clinical research.
If we truly aim to be patient-centered, we must take a measured & patient-first approach to sensors.
The technology will follow.”
The Resource
We have used The Playbook to educate both internally and externally about how we need to reshape and reorder our thinking as it relates to connected sensors and wearables. As a technology company with an enthusiasm for exploring innovative and interesting technology workflows, if we truly aim to be patient-centered, we must take a measured & patient-first approach to sensors. The technology will follow.
"Start with the measures" has been an incredibly powerful and simple idea to realign our approach and to have more effective conversations with sponsors considering remote measures via connected sensors.
Medable is solving many of the longest standing challenges in healthcare: cost, time, and access to clinical trials. This mission is realized through a decentralized clinical trial platform that’s proven to shorten trial timelines, capture efficiencies in research, and expand clinical trial access to every body and every biology.
The Playbook will become a well trusted reference for academics and commercial entities alike.”
The Resource
The Playbook has been a wonderful additional tool to point to for our customers. It helps align their understanding and expectations and supports the internal perspective we have built over the past several years as part of our NIH funded work.
As scientific expertise in this area grows and programs are built around digital measures that matter to patients and have clinical impact, the playbook will become a well trusted reference for academics and commercial entities alike.
Medable is solving many of the longest standing challenges in healthcare: cost, time, and access to clinical trials. This mission is realized through a decentralized clinical trial platform that’s proven to shorten trial timelines, capture efficiencies in research, and expand clinical trial access to every body and every biology.
The Playbook provides a practical ‘how to’ guide for trial teams on coordinating the multi-functional efforts involved in implementation of digital measures in clinical trials”
The Problem
Highly cross-functional efforts are needed to enable successful implementation of digital health technologies (DHTs) and use of digital clinical measures in clinical trials. ��We sought to develop resources for our multidisciplinary clinical trial teams to document best practices and considerations throughout the technology selection, trial planning, and execution processes and enable smooth coordination across functions.
The Resource
We are leveraging The Playbook and the following dossiers in building internal resources for clinical trial teams
The Impact
✓ Operational efficiency ✓ Clear communication with Internal team ✓ Team education & cohesion
For more than 130 years, Merck (known as MSD outside of the U.S. and Canada) has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives.
The Playbook(s) provided a useful reference and a single place where we could find the answers to many questions as well as credibility to our work.”
The Problem
We had to create internal educational materials for colleagues and leadership, to enable decentralized clinical trials and to get buy-in and support for our projects.
The Resources
We used The Playbook in its entirety as a reference guide as well as the micro playbooks on "Pharma Execs" and "510(k) need for devices" to refine our internal strategy
And, we used the suite of Playbook resources as a backbone for our own Playbook on Decentralized Clinical Trials and to support a dozen or so trials in 2021, leveraging digital devices for remote monitoring, biomarkers, at-home data collection, etc.
The Impact
✓ Project success ✓ Greater patient centricity ✓ Clear communication internally - team ✓ Clear communication internally - execs ✓ Operational efficiencies / faster decision making ✓ Team education and cohesion ✓ Refined / Improved strategy
Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.
Having a common language from which to operate regardless of background or expertise has helped improve efficiency and project outcomes both internally and externally.”
The Problem
Successful development and implementation of digital clinical measures requires experts that span a spectrum of disciplines including, data science, hardware and software engineering, regulatory, clinical research and medicine.
Effective communication across multidisciplinary teams cannot be taken for granted. It is important for us to enter conversations with clients and collaborators using a shared language.
The Resources
To help improve communication we have implemented the Masterclass Series for all new (and old) hires and refer often to the Glossary on The Playbook website. Having a common language from which to operate regardless of background or expertise has helped improve efficiency and project outcomes both internally and externally.
The Impact
✓ Operational efficiency ✓ Clear communication with pharma partners ✓ Team education & cohesion
VivoSense is an agile end-to-end scientific solutions company developing novel digital endpoints from wearable sensor data. We are focused on healthcare research & delivery, clinical trials and patient wellness. Our hypothesis-driven framework provides analytical and clinical validation leading to FDA approval.
The fact that these tools were collaboratively developed by a diverse group of experts with various stakes has made it an invaluable resource that we can confidently reference.”
The Problem
Pharmaceutical clients frequently approach us with a specific use case - they want to use a specific sensor in a specific clinical population to measure a specific endpoint.
Prior to the Measurement Dossier and the V3 framework published by DiMe, the large majority of these conversations were uphill battles, with clients not fully understanding why or when additional validation is required.
The Resource
We use the Measurement Dossier to help guide internal R&D decisions and recommendations to external clients. Part of our job at VivoSense is to evaluate the state of existing analytical and clinical validity evidence relevant for the specific use case, identify any missing pieces and make recommendations on how to most effectively move forward with the project or conduct additional validation activities. �
The Measurement Dossier directly and concisely outlines the level of evidentiary requirements needed for digital clinical measures throughout the drug development process.
The Impact
✓ Operational efficiency
�✓ Clear communication with
pharma clients
VivoSense is an agile end-to-end scientific solutions company developing novel digital endpoints from wearable sensor data. We are focused on healthcare research & delivery, clinical trials and patient wellness. Our hypothesis-driven framework provides analytical and clinical validation leading to FDA approval.
Patient-centricity is critical to novel biomarker development. The Playbook establishes best practices for patient engagement, including a practical how-to for the industry to follow.”
The Problem
Patient engagement, early and often, is critical to developing novel digital measures. Being patient-focused means developing measures derived from patient feedback, including a clear understanding of the aspects of health matter to patients.
We have the opportunity to re-define clinical measurement of speech and language by building novel measures that capture health concepts that are meaningful to patients.
The Resource
The Playbook presents a framework, including questions to ask patients at each step, that walks users through how to gather patient feedback with the aim of developing meaningful measures. The example questions and step-by-step guide from "Meaningful aspect of heath" to "Outcome to be measured" establishes best practice in patient engagement for the field to follow.
When developing new speech-based digital tools, we use the "measures that matter to patients" framework from The Playbook to guide patient interviews and to ensure we're building high quality, patient-centric measures of health.
The Impact
✓ Clear communication with internal team ✓ Team education & cohesion ✓ Greater patient- centricity ✓ Operational efficiencies and/or faster decision making
Winterlight Labs has developed an automated speech analysis platform to monitor neurodegenerative and psychiatric conditions. Our tools are objective, sensitive, and easy-to-use, and are used by 5 of the top 10 Life Sciences companies to monitor disease progression and response to treatment.
The measurement checklists provide a framework for best practices in developing and validating novel digital measures. These will help bring consistency and scientific rigour to the field! ”
The Problem
Winterlight's technology is currently used as an exploratory endpoint in a number of clinical trials in neurodegenerative disorders. As we collect data in more indications and further develop our technology, we want to work toward being validated as a secondary or primary endpoint.
The Resource
The Measurement Checklists on The Playbook website provide useful summaries of the types of evidence and clinical data required for different contexts of use. These checklists have helped inform our validation strategy and guide our research program into how speech is affected in various disease and disorders. We can use these frameworks to organize our existing data, know what to communicate to our partners, and define our next steps for research and validation.
Winterlight Labs has developed an automated speech analysis platform to monitor neurodegenerative and psychiatric conditions. Our tools are objective, sensitive, and easy-to-use, and are used by 5 of the top 10 Life Sciences companies to monitor disease progression and response to treatment.
The Impact
“If you're interested in learning more about #remotemonitoring across #clinical research, clinical care, and #publichealth - with a specific focus on connected #sensor products - DiMe Playbook is your one stop shop.”
The Problem
As a startup in the DCT space, we are accelerating innovation using more connected digital infrastructure which can capture RWD for participants in clinical trials who need to be continuous ambient monitoring. For this we needed to build processes that would help us:
The Resource
We used the following pages from The Playbook to address these challenges directly:
Page 216: Benchmarking can identify the best measure when there are multiple approaches to measuring the same concept
Page 259: Should I use an eCOA or a digital biomarker as my endpoint?
Page 188: Fundamentals for clinicians / Redefining patient safety / Ethics: Ethical considerations in technology selection
The Impact
✓ Project success ✓ Greater patient centricity ✓ Operational efficiencies and/or faster decision making ✓ Team education and cohesion ✓ Refined/improved strategy ✓ Area knowledge/subject matter
WKD.SMRT enables clinical trials to be faster, easier, lower cost, and lower risk by providing more powerful in-home real-life data. Using the power and reach of technology the WKD.SMRT system provides access to clinical trial participants in their own home, no matter where they live, with superior retention and adherence.
>>>
>>>
>>>
The Playbook in action:
Case Study Library
(Last update: October 4, 2021)