Recent FDA Guidance Documents on Clinical Trials: Decentralized Clinical Trials, Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice, Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs, and Diversity Action Plans

Description: The FDA has recently issued several guidance documents as part of the Agency’s ongoing efforts to modernize its policies for the conduct of clinical trials.  These include:

• A final guidance on “Conducting Clinical Trials With Decentralized Elements” (the “DCT Final Guidance”);
• A draft guidance on “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice” (the “Routine Clinical Practice Trials Draft Guidance”);
• A draft guidance on “Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs” (the “Oncology Multiregional Clinical Development Programs Guidance”); and
• A draft guidance on “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (the “DAP Draft Guidance”).

During this R3 session, we will provide an overview of each of these guidance documents, discuss thematic intersections between them, and address practical implications for study sponsors, investigators and sites.  With respect to the DCT Final Guidance, we will also look at how the final guidance addressed the MRCT Center’s extensive comments on the draft guidance.

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This meeting is open to sponsors of the Research, Development, & Regulatory Roundtable. To learn about how to become a sponsor, please contact us at mrct@bwh.harvard.edu