Clinical Trials for DTx
To be recognized on par with medications and other clinically-evaluated therapies, all digital therapeutic products must demonstrate their ability to improve patient outcomes through peer-reviewed research. This involves adhering to industry-adopted core principles, including undergoing adequate and well-controlled clinical investigations.
Every product in healthcare that delivers a direct clinical intervention and claims to produce a specific outcome must undergo pre-market clinical evaluation. Most often taking the form of a Randomized Control Trial (RCT), these pre-market evaluations assess the safety and efficacy of a product.
Innovation must continue to be paired with scientific rigor as the DTx industry evolves. Partnerships between digital therapeutic and life science companies, healthcare providers, academia, and payers are crucial to ensuring that the design, evaluation, deployment, and utilization of digital therapeutics are fully evidence-based.