Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical Trials

K&L Gates Health Care Triage

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical trials, as well as notable planning considerations and regulatory requirements for both the industry sponsors and the academic medical centers, research institutions and other providers participating in clinical studies.