Inside an Individual’s Physiological Signature
John Varaklis: January 27, 2023
Originally published in Medical Device & Technology
Originally published in The Digital Medicine Society (DiMe)
The Digital Medicine Society (DiMe) today announced its next open-science collaboration of stakeholders across clinical, technology, and nonprofit sectors, government, and academia to deploy The Digital Clinical Measures Playbook (The Playbook), the essential industry guide for remote patient monitoring in clinical research, clinical care and public health.
The goal of this 'Tour of Duty' is to drive adoption of The Playbook as the shared foundation for advancing digital clinical measurement and transforming clinical trials, patient care and public health through remote monitoring.
"In recent years we've seen an explosion of promising digital health technologies from simple consumer health apps to sophisticated, evidence-based digital therapeutics to treat disease," said DiMe Executive Director Jennifer Goldsack. "The Playbook standardizes and guides the safe and effective use of digital clinical measures and helps to ensure an analytical and clinical evidence base for these technologies for the benefit of patients worldwide."
The global COVID-19 pandemic has brought new urgency to the drive toward devising a common framework for the development and deployment of high quality, patient centric, digital clinical measures. Multiple digital technologies for symptom tracking and contact tracing are currently in use and/or development, and clinical researchers are now designing new decentralized clinical trial strategies using telemedicine and remote patient monitoring to minimize pandemic-related disruption of the clinical research enterprise. Adoption of a comprehensive "how-to" roadmap to synthesize best practices in the digital health field is essential for guiding these efforts and safeguarding public health.
The Playbook, launched in September, 2020, was the culmination of a six-month Tour of Duty driven by multidisciplinary participants from DiMe, Elektra Labs; Genentech, a member of the Roche Group; Koneksa Health; MyoKardia; Sage Bionetworks; Scripps Research; and the U.S. Food & Drug Administration.
Convened by DiMe for the second Tour, founding partners are joined by ActiGraph; Activinsights; American Pharmacists Association; BlackThorne Rx; Center for Digital Health at Brown University; Covance; Digital.Health; Duke University; Eli Lilly and Company; the European Medicines Agency; Evidation Health; Merck and Co., Inc.; Open mHealth; Pfizer; physIQ; Savvy Coop; Takeda; VivoSense; and Winterlight Labs.
'Tours of Duty' (TOD) are the cornerstone of DiMe's strategy for developing clinical quality evidence on a rapid tech timeline. They are collaborative, open-science sprint efforts of four to six months, each addressing a pressing challenge needed to advance the safe, effective, ethical, and equitable use of digital technologies to improve public health.
This next Tour is dedicated to establishing The Playbook as the shared foundation for digital clinical measurement and will drive several workstreams over the coming months to refine content and crystallize consensus, develop illustrative use cases, articulate optimal strategy and ROI for the use of remote monitoring, and advance educational initiatives. Conveners anticipate releasing these additional resources through April 2021.
What Tour of Duty participants are saying:
"We are on the brink of digital clinical measures going from being seen as "nice to have" to becoming critically important and absolutely necessary. The Playbook will help demonstrate to pharma companies, academic institutions and regulatory agencies the value of including digital endpoints in ALL clinical studies." David Caouette, Executive Director, Head of Digital Data Science & the PfIRe Lab, ECD, Pfizer
"I see the great impact that can be made for patients when health can be measured outside of the clinic and with measures that matter to patients." Bray Patrick-Lake, Director of Strategic Partnerships, Evidation Health.
"This is a big opportunity to be part of something much bigger than any single project; being able to help shape the landscape and influence the digital health field is extremely exciting to me!" Jie Ren, Associate Principal Scientist, Merck & Co., Inc.
"(The Playbook) provides a common set of language, simple frameworks, grounded in practical user needs rather than theoretical issues. It's simplified many conversations and we're able to move faster when deploying digital tools into clinical trials." Andy Coravos, CEO Elektra Labs.
"Digital clinical measures are new, exciting and very much under development. Having a standard framework for their development and use will help the field move forward by setting best practices and encouraging adoption of these novel measures." Jessica Robin, Director of Clinical Research, Winterlight Labs
"(The Playbook) helps provide objective clarity on including technology or new methods in projects." Matt Biggs, Head of Business Operations, ActiGraph, LLC
The Playbook is available at https://playbook.dimesociety.org/.
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
Staci L. Vernick
Communications, Digital Medicine Society
staci@dimesociety.org
SOURCE Digital Medicine Society (DiMe)
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