The Playbook guides the safe and effective use of digital clinical measures across clinical research, patient care and public health

This open science effort is unveiled by stakeholders at Digital Medicine Society, Elektra Labs, Genentech, Koneksa, Myokardia, Sage Bionetworks, and Scripps Research.

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Digital Medicine Society (DiMe)

Sep 17, 2020, 15:13 ET

BOSTON, Sept. 17, 2020 /PRNewswire/ -- Today, multidisciplinary stakeholders invite partners across clinical, technology, nonprofit, and academic research to shape the industry-wide essential guide for developing and deploying digital clinical measures to advance patient care, clinical research, and public health. The Digital Measures Playbook (The Playbook) will synthesize best practices from the digital health field into one comprehensive "how-to" document. A first draft, built by collaborators from the Digital Medicine Society, Elektra Labs, Genentech, a member of the Roche Group, Koneksa, Myokardia, Sage Bionetworks, and Scripps Research.

Unveiling of The Playbook marks the successful conclusion of a "Tour of Duty" by the multi-stakeholder group, which was convened to create a first draft for review, synthesizing work that has previously existed in silos. As part of The Playbook's unveiling, stakeholders are seeking additional partners to advance this open science effort, becoming part of the inaugural cohort that will further develop this public good and drive wide scale industry adoption for the betterment of patients worldwide.

"Remote monitoring technologies are now advanced in their capabilities to detect symptoms of health and disease," explains Tour of Duty member and executive director of the Digital Medicine Society, Jennifer Goldsack, "Yet under the pressure of a global public health crisis, we were unable to deploy them at scale in clinical research, routine care, or in public health initiatives. The Playbook will address the lack of experience implementing these technologies, taking academic frameworks, stitching them together, and providing a 'how to' guide to get it done."

"Technology has always moved faster than our ability to safeguard it," said Tour of Duty member and CEO of Elektra Labs, Andy Coravos. "The Playbook will provide the foundational elements of developing and deploying high quality digital clinical measures that cut across use cases and positioning our field for a shared digital health data ecosystem."

The draft of The Playbook is available for public comment at playbook.dimesociety.org, along with links to sign up for future Tours of Duty. The launch of The Playbook will be followed by an educational series, "The Playbook Masterclass" series, with interdisciplinary experts leading instructional sessions on core topics through the fall.

The Digital Medicine Society

The Digital Medicine Society (DiMe) is the professional society serving the digital medicine community. Together, we drive scientific progress and broad acceptance of digital medicine to enhance public health.

Media Contact: Michelle Sechser [email protected]

The following quotes are from the organizations that co-created The Playbook for further development by industry:

Mark Lee, MD PhD, Global Head of Personalized Healthcare, Product Development, Genentech

"Remote monitoring technology gives us important, real-time data and insights for each patient's unique disease course, enhancing our ability to develop medicines -- and how and when to best deliver them -- to truly improve patient outcomes in more personalized and meaningful ways - Mark Lee MD PhD, Global Head of Personalized Healthcare, Product Development, Roche/Genentech"

Genentech MEDIA CONTACT: Andrew Villani [email protected]

Chris Benko, CEO, Koneksa Health

"Digital measures enable a trifecta of drug-development goals: greater scientific understanding, more patient centric assessments and improved access to clinical trials. Breakthrough therapies are needed more than ever and these technologies give us not only the opportunity to improve outcomes, but to improve the patient experience at the same time."

Koneksa Health MEDIA CONTACT: [email protected]

Priyanka Agarwal, Director of Digital Health, Myokardia

"Remote monitoring has the possibility to truly revolutionize how decentralized clinical trials are operationalized. This work is vitally important today, especially in the context of COVID-19 and the unprecedented times we find ourselves in."

Myokardia MEDIA CONTACT: Michelle Corral [email protected]

Lara Mangravite, President, Sage Bionetworks

"Getting to reliable results from digital health tools may not be easy, but it's not magic. The Playbook breaks down the processes and practices that we need as a profession to make good science happen from new tools, especially validation, benchmarking, and strong ethics."

Sage Bionetworks MEDIA CONTACT: Hsiao-Ching Chou [email protected]

Steve Steinhubl, Director of Digital Medicine, Scripps Research

"The use of digital technologies to enable direct-to-participant research provides remarkable opportunities to overcome many of the current limitations of traditional research, but also many challenges. Sharing our learnings will help accelerate its adoption and with it, improvement in health outcomes."