Digital endpoints: Global opportunities and clinical, data protection and other challenges

In order to present evidence of a drug’s efficacy for regulatory approval, manufacturers provide data on endpoints, or measurable outcomes used to address the objectives of a clinical trial. Digital endpoints are novel endpoints like smartphone microphones, wearables, and digital pills to allow more frequent, objective remote monitoring of patients during clinical trials. Currently, digital endpoints have yet to be accepted in support of new drug approvals within the U.S., but recent FDA draft guidance signals regulatory acceptance of digital endpoints may occur in the short-term. Read more about the risks, challenges and legal liabilities of digital endpoints that innovators should consider in our latest article for MedCity News, available here.