Premier Comments on FDA Draft Guidance on Decentralized Clinical Trials

Premier submitted comments in response to the FDA’s draft guidance on decentralized clinical trials for drugs, biological products and devices. The draft guidance will provide much-needed clarity into the implementation of decentralized and hybrid clinical trials, spurring innovation in clinical trials. Premier supports the new draft guidance as a positive step towards recognizing the ways in which technology can be leveraged to reduce costs, expedite processes and improve diversity in clinical trials. In its comments, Premier applauded the FDA’s efforts to expand clinical trial access for patients and provide clarity for clinical trial innovators and urged the agency to expeditiously finalize the draft guidance to ensure that federal requirements for decentralized clinical trials are fully harmonized. Premier also offered a host of recommendations to ensure that the standards, requirements, guardrails and regulatory applicability around decentralized clinical trials enables their success.