The rise of digital therapeutics and PGHD
Pear Therapeutics is making strides with Somryst, enrolling their first participants in a fully decentralized study (DREAM) to evaluate the effectiveness of the prescription digital therapeutic for people with chronic insomnia. Meanwhile, Pear’s former partner Novartis recently joined forces with Propeller Health to co-package the Enerzair Breezhaler, making Propeller’s digital adherence and symptom tracking tool available to asthma patients. This trend in the uptake of digital health tools available as prescribed treatments can be seen in Germany’s recent reimbursement reforms for Digital Health Applications in the Digital Healthcare Act. Back in the U.S., the final version of the FDA’s Patient-Focused Drug Development guidance was published in June, including recommendations for collecting patient experience data to illuminate how patients are functioning in their day-to-day lives. This FDA guidance reflects the growing importance of person-generated health data in patient monitoring, health measurement, and novel endpoint development. The recently published REALIsM-HF study shows the potential to harness this data from wearable devices and ePROs to create digital endpoints for future heart failure trials.
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Research: Evidation recently published one of the first manuscripts comparing study samples recruited with virtual versus traditional recruitment methods in Contemporary Clinical Trials Communications. The main takeaway: virtual recruitment may enhance efficiency and enable more individuals to participate in clinical research. We also published a 1-year mental health observational study; the results suggest that longitudinal behavioral and health outcomes data may be useful for developing digital measures of health for mental health symptom severity and progression.
Partnerships: We’re excited about our partnership with BlackDoctor.org, Movember, and Myovant Sciences to launch Forward Momentum: a cross-sector coalition working to improve representation in research.
Announcement: We’re very excited to have Sam Marwaha, formerly a Senior Partner at Boston Consulting Group and long-time advisor to Evidation, join the company as Chief Commercial Officer! Read more about his role and Evidation’s Series D. We also recently announced a new effort to develop an early warning algorithm to detect symptoms of COVID-19 and to understand susceptibility to infection, funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) and the Bill & Melinda Gates Foundation.