THE PLAYBOOK: DRIVING ADOPTION IS THE FOUNDATION FOR BUILDING TRUST IN DIGITAL MEASUREMENT AND REMOTE MONITORING IN CLINICAL TRIALS, PATIENT CARE, AND PUBLIC HEALTH
Amid the COVID-19 pandemic, leading companies from life sciences, healthcare, and technology came together alongside patient experts and regulators in an unprecedented pre-competitive collaboration
April 30, 2021 Boston (MA) The Digital Medicine Society (DiMe) today announced during a public meeting the launch of its new website and materials to promote the use of The Playbook to advance digital clinical measures across healthcare. It includes a refreshed version of The Digital Measures Playbook (“The Playbook”) and over 100 fit-for-purpose resources.
The Playbook was first launched in September 2020 and is the essential guide for developing and deploying digital clinical measures to advance patient care, clinical research, and public health.
This project convened 29 leading organizations during the greatest public health crisis of our lifetimes with the shared goal of driving adoption of digital clinical measures, in what was truly an unprecedented pre-competitive collaboration. Each organization committed resources and expertise to identify and implement the most valuable ways in which The Playbook could be improved and advanced.
According to DiMe executive director Jennifer Goldsack, the goal is to drive broad adoption of digital-health technologies and establish The Playbook as “the gold standard” for successful remote monitoring.
“Leading organizations from life sciences, healthcare and technology have come together with colleagues from the patient and global regulatory communities to demonstrate how The Playbook can be used by clinicians, researchers and policymakers to make better decisions, faster,” said Goldsack. “We are honored to have hosted this world-class collaboration and applaud the commitment of every participating organization to advancing the field while under the pressure of the greatest public health crisis of our lifetimes. This work offers a complete and comprehensive toolkit for developing and deploying effective and trustworthy digital clinical measures and I believe it will transform the field.”
The new suite of Playbook resources were designed to provide relevant, accessible, and action oriented resources on key topics for target audiences such as pharma, healthcare executives, policy makers, and front-line providers.
Projects 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.
The Playbook and Playbook resources are available at https://playbook.dimesociety.org/
What project participants are saying:
“An experience that brought my vision of the future to the immediate present”
-Ariel E. Aguiló, MD, Senior Medical Director, Oncology, Covance by Labcorp
“Digital biomarkers are transforming the way we measure new medicines in clinical development. We’re proud to be among the leaders in the life-sciences industry working to speed this evolution and make sure these innovative tools are changing the lives of patients.”
-Chris Benko, CEO, Koneksa Health
“This Tour builds on The Playbook to make it more digestible and useful to those on the frontlines of driving innovation and the adoption of digital health tools.”
-Ieuan Clay, Market Development and Innovation, Evidation Health
“Participating in the DiMe Tour of Duty provided an excellent opportunity to collaborate with fellow experts in the field of digital medicine and demonstrate the value and impact of including digital endpoints in clinical studies and decentralized trials.”
-David Caouette, Executive Director, Head of Digital Data Science & the PfIRe Lab, ECD, Pfizer Pfizer
“It was a pleasure and an honor to participate in this work on The Playbook. It is not only what we created together, but also how we created it. What we created is tangible: all the resources created during the Tour of Duty are publicly available to be read, consulted, implemented, commented upon. How we created it is something less tangible that each of us will carry as an experience to be replicated: clear objectives, sparkling discussions within groups large and small, focus on the tasks at hand, active listening, and trust in DiMe’s vision for the overall project.”
-Simona Carini, Data Scientist, Open mHealth
“As medicine swiftly adopts new technologies during this COVID-19 era, it can be hard to figure out where you are on the map. The Playbook offers a “you are here” orientation and jumping off point with over 100 resources to best integrate safe, effective, and ethical digital clinical measures into your work.”
-Andy Coravos, Co-founder and CEO, Elektra Labs
“The Playbook makes it easy for both newcomers and practitioners of digital health to find relevant materials and stay up-to-date on the latest guidance in care, research, and policy.”
-Jessilyn Dunn, Assistant Professor, Department of Biomedical Engineering, Department of Biostatistics & Bioinformatics, Duke University; Director, BIG IDEAs Lab, Duke University
“The Playbook will accelerate time-to-market, improve overall quality, align with regulatory expectations, and most importantly serve patients’ needs. I’m proud of the work DiMe has done since the initial release of The Playbook, and of the team’s drive for continuous improvement.”
-Pablo Gersberg, Senior Vice President, Business Technology and Digital Health, Blackthorn Therapeutics
“The Tour was a terrific opportunity to come together with other leading companies and stakeholders from around the world to create the resources and roadmaps necessary to increase adoption of digital clinical measures. The Playbook provides practical “how-to” tools, as well as case studies to support executive buy-in, so we can truly measure what matters most to patients. My hat is off to DiMe for leading such a powerful, field shaping effort.”
-Bray Patrick-Lake, MFS, Senior Director, Strategic Partnerships, Evidation Health
“I’m confident that the resources we’ve produced through the Tour of Duty will be a game changer for the industry and for the patients who will ultimately benefit from these digital tools. With The Playbook in hand, I believe key stakeholders will finally be properly equipped to effectively bring digital measures into clinical studies.”
-Jeremy Wyatt, CEO, The Actigraph
DIGITAL MEDICINE SOCIETY LAUNCHES ‘TOUR OF DUTY’ FOR
THE DIGITAL MEASURES PLAYBOOK TO ADVANCE HEALTHCARE
World-class Team of Tech, Pharma and Clinical Leaders Join Regulators and Patient Advocates to Drive
the Development and Deployment of Digital Clinical Measures for Remote Patient Monitoring Through
COVID-19 Pandemic and Beyond
Boston, MA, NOVEMBER 18, 2020 – 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 Therapeutics; 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.