REdI 2024 | D2S06 - Reimagining Clinical Research: The Transformation of Trial Design & Conduct

This presentation explored the transformation of clinical research through innovative approaches to study design, execution, and assessment. The session emphasized Quality by Design principles and highlighted FDA/CDER Clinical Trial Innovation Programs, including the Center for Clinical Trial Innovation (C3TI). The role of perspective in clinical research transformation was discussed, and a lightning round segment debunked common FDA myths to clarify misconceptions about regulatory processes and requirements. Timestamps 03:21 – Study Design, Execution, and Assessment 13:25 – Quality By Design 22:34 – CDER’s Clinical Trial Innovation Programs 25:24 – CDER Center for Clinical Trial Innovation (C3TI) 30:39 – The Role of Perspective 30:43 – Lightning Round: Debunk FDA Myths 43:19 – Questions Speakers: Dave Burrow, PharmD, JD Director Office of Scientific Investigations (OSI) Center for Drug Evaluation and Research (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 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