The unique clinical trial challenges faced by digital therapeutics

Among the many struggles faced by the digital therapeutics industry is the difficulty of designing and running effective clinical trials of digital therapeutics. As a yet young category, they often face uncharted regulatory waters. And the extensive data collection that's possible with digital therapeutics can become a double-edged sword when it adds cost and complexity to trials.

On today’s podcast, host Jonah Comstock is joined by Meri Beckwith, co-founder of Lindus Health, a next-gen CRO that includes digital therapeutics among its specialties. They talk a little bit about the often unseen difficulties of validating a digital therapeutic through a clinical trial.

Among other things, they discuss regulatory and reimbursement uncertainties, the dangers of treating digital therapeutics too much like drugs, and considerations for how to design a good clinical trial for digital therapeutics – including the pros and cons of “sham apps” and how to avoid overburdening patients.

Of course, Beckwith also talks a bit about Lindus Health’s “anti-CRO” model and how it better aligns incentives for trial sponsors, and both host and guest venture some predictions about how digital therapeutics regulation and business models will evolve in the future. Tune in for a peek into the surprisingly complex world of digital therapeutics evidence generation.

You can listen to episode 118 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it – and subscribe to the rest of the series - in iTunes, Spotify, acast, Stitcher, and Podbean.