About

The Digital Clinical Measures Playbook (The Playbook) is the essential guide for remote patient monitoring A technology-based system of enabling monitoring of patients outside of conventional clinical settings, such as in the home or in a remote area. Allows for collection of data in real time in a real life setting. in clinical research, clinical care and public health. The Playbook synthesizes best practices from the digital health field into one comprehensive and accessible “how-to” guide to support all the stakeholders participating in the development and deployment of digital clinical measures Health outcomes or physiological characteristics of an individual’s health, wellness, and/or condition that are collected digitally with a sensor.. It is applicable to everyone — from experienced expert to novice — working to advance the safe, effective, ethical, and equitable use of digital clinical measures to improve lives.

The Playbook: The Story So Far

The Playbook was launched for public comment in September 2020 and is maintained by global leaders in digital clinical measures as a living resource. Read The Playbook’s origin story, meet the experts who created it, and learn more about our shared goals in creating the methodological gold standard for developing and deploying digital clinical measures.

Tour of Duty: The Playbook

On September 17, 2020, cross-industry stakeholders at Digital Medicine Society, Elektra Labs, Genentech, Koneksa, MyoKardia, Sage Bionetworks, Scripps Research, and the US Food and Drug Administration launched The Digital Clinical Measures Playbook (The Playbook), the essential guide for remote patient monitoring in clinical research, clinical care and public health.

This ‘Tour of Duty’ convened inter-industry stakeholders from clinical, technology, and nonprofit sectors, government, and academia to synthesize best practices from the digital health field, breaking down silos to create one comprehensive and accessible “how-to” guide to support all stakeholders working to advance the safe, effective, ethical, and equitable use of digital clinical measures to improve lives.

The Playbook was unveiled during a public meeting attended by over 350 experts from 200+ organizations from four continents. It was downloaded over 700 times in the first 24 hours and over 2,000 times in the first ten days following launch.

Tour of Duty: Driving Adoption

Amid the greatest public health crisis of our lifetimes, leading companies from life sciences, healthcare, and technology came together alongside patient experts and regulators to drive adoption of The Digital Measures Playbook as the foundation for digital measurement and remote monitoring in clinical trials, patient care, and public health. This pre-competitive collaborative Tour of Duty, known as “The Playbook: Driving Adoption,” was facilitated by the Digital Medicine Society and brings together 44 participants from the following 29 organizations:

ActiGraph; Activinsights; American Pharmacists Association; BlackThorn Therapeutics; Brown-Lifespan Center for Digital Health; Covance by Labcorp; Digital.Health; Duke University; Elektra Labs; Eli Lilly and Company; the European Medicines Agency; Evidation Health; Genentech, a member of the Roche Group; Koneksa Health; Merck and Co., Inc.; MyoKardia; Sage Bionetworks; Open mHealth; Pfizer; physIQ; Savvy Coop; Scripps Research; Takeda; the U.S. Food & Drug Administration; VivoSense; and Winterlight Labs.

Participants in this Tour of Duty shared the goal of establishing The Playbook as the gold-standard for developing and deploying digital clinical measures.

Tour of Duty: Driving Adoption - Launch Event

On April 30, 2021, DiMe hosted a virtual event to demonstrate how you can use the new Playbook resources to advance the field of digital medicine. Listen to Dr Amy Abernethy, former Principal Deputy Commissioner, US FDA deliver the keynote remarks below.

The individual panels have been included in the relevant dossiers. Pro tip: the “Mitigating Risks” panel is included in the Pre-Mortem Use Case page.