Strategies To Unlock Excellence In Digital Health Technology Clinical Trials

By Shaheen Lakhan, M.D., Ph.D., FAAN, Chief Medical Officer, Click Therapeutics; Bob Schafer, Ph.D., CEO, Lumos Labs (Lumosity); John A. Wagner, M.D., Ph.D., Chief Medical Officer, Koneksa Health; and Nicole Latimer, Chief Executive Officer, Medrio

Digital health technologies (DHTs) are gaining momentum, with around 23 digital therapeutics (DTx) approved or cleared by the FDA as of December 2022 for illness prevention and treatment. The market is rich with various digital health tools aiding patients in managing their well-being. Despite this progress, organizations encounter challenges. A recent discussion among DHT experts, including Nicole Latimer, Shaheen Lakhan, Bob Schafer, and John A. Wagner, delved into the current landscape, successful clinical trial strategies, and the journey to regulatory approval.

The experts explored why companies seek regulatory approval, emphasizing how defining a product's purpose influences its regulatory status. They also highlighted the role of digital biomarkers in DHT trials, advocated for conducting more, albeit smaller, trials as a viable strategy, and emphasized the value of consulting regulatory bodies to alleviate confusion. Gain a comprehensive understanding of technology's impact on patients, considerations in selecting partners, and potential challenges in DHT trials by accessing the full article below.