When smartphone-powered fitness trackers emerged, clinical researchers, life science professionals, and academic researchers immediately saw the potential for real-time data synchronization and data summary visualizations for end users.1 Their interest initially sparked rushed, incomplete efforts and suboptimal pilot studies that were designed and deployed without a comprehensive understanding of how to perform remote monitoring clinical experiments and obtain meaningful health information.
This challenge was recognized by the Digital Medicine Society (DiMe), a professional organization that advances the field of digital medicine through collaboration, research, education, and best practices. To promote the safe, effective use of digital health technologies, DiMe’s multidisciplinary group of industry leaders, regulators, and patient advocates came together to standardize best practices and support the growing analytical and clinical evidence base for digital medicine.
The result of this open-science collaboration was The Playbook, a 400-page manual for developing and deploying digital clinical measures and remote monitoring across clinical research, clinical care, and public health. This action-oriented guide shares strategies for some of the most important elements of pursuing modern digital medicine.
- How to evaluate technologies to suit patient and population needs
- How to plan and deploy collaborative remote monitoring operations
- How to manage the ethical implications of technology in healthcare
- How to benchmark and set standards for digital clinical measures
- How to navigate legislation and regulation in the digital health space
Understanding The Playbook’s Real-World Impact
COVID-19 has contributed to the increased exploration of digital clinical measures and the growing demand for more convenient, patient-centric monitoring methods. Remote monitoring is gaining traction in clinical trials, proving its ability to accelerate operations and uncover meaningful signals from datasets while freeing participants from time-consuming waits, site access issues, and costly payments. As digital tools and strategies evolve in healthcare, comprehensive resources grounded in real-world experience like DiMe’s manual are invaluable.
A founding partner of The Playbook and an active participant in its first Tour of Duty, Koneksa has seen its impact in recent clinical studies. One of our earliest collaborations for digital biomarker deployment was with Montefiore Medical Center, utilizing fitness trackers to monitor physical activity remotely, objectively, and systematically in Dr. Nitin Ohri’s oncology research. With this study’s data, physicians were more informed in assessing patient functional status and eligibility for clinical trials or new therapies, which revealed new opportunities to enhance care delivery.
The Playbook offers practical advice on how to think through processes in a compliant way that allows solutions like Koneksa’s to be successful. We’re committed to advancing digital medicine and facilitating the early adoption of digital tools with The Playbook as our guide. Read our digest article to learn more about this important DiMe resource and its application in Dr. Nitin Ohri’s study.
1 Fit-for-Purpose Biometric Monitoring Technologies: Leveraging the Laboratory Biomarker Experience. Godfrey A, Vandendriessche B, Bakker JP, Fitzer-Attas C, Gujar N, Hobbs M, et al. Clin Transl Sci. (2020)