CITC 2024 – D1S02 – Basics of Clinical Trial Design

Learn the essential principles behind rigorous clinical research that supports FDA drug approvals. This video covered the key elements that make clinical studies reliable and scientifically sound, including what makes a study "adequate and well-controlled" according to FDA standards. Explore why control groups are critical for determining drug effectiveness, examine different types of controls used in clinical investigations, and discuss proven methods researchers use to minimize bias and ensure objective results. Timestamps 00:34 – Adequate & Well-Controlled Studies 05:33 – Purpose of Control Groups 18:13 – Methods of Assignment to Study Arms 23:03 – Measures to Reduce Bias 27:37 – Assessing Response / Endpoints 32:53 – Intercurrent Events 43:22 – Other Design Considerations 47:49 – Summary Speaker: James P. Smith, MD, MS Director Office of New Drug Policy (ONDP) Office of New Drugs (OND) CDER | FDA Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...   SBIA 2025 Playlist -    • 2025 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367