Overview
How can we make trials more responsive to accumulating evidence while maintaining statistical rigour?
Bayesian techniques add new data to existing knowledge to estimate the probability that a treatment works, updating effectiveness probabilities as new data emerge. Despite growing utilisation in clinical trials over the past two decades, regulatory guidance has remained inconsistent, leaving researchers and pharmaceutical companies uncertain about the standards to be met when seeking regulatory approval.
That changed in January this year, when the U.S. Food and Drug Administration (FDA) Centers for Drug Evaluation and Research and Biologics Evaluation and Research (CDER) released draft guidance specifically addressing the use and reporting of Bayesian methodology in clinical trials for therapeutic agents. The publication of this guidance demonstrates the changing landscape of trial conduct as regulatory bodies such as the FDA begin embracing Bayesian techniques.
In this Global Leaders in Biostatistics and Epidemiology (GLIBE) Webinar, Prof Frank Harrell will walk attendees through key aspects of the guidance and explore what it means in practice. His presentation will also examine how Bayesian and frequentist approaches differ in their interpretation of results, and why the differences matter for trial design and decision-making.
Schedule
Date: 21 Oct 2026, Wednesday
Time: 9:30 AM - 10:30 AM (GMT +8:00) Kuala Lumpur, Singapore
Location: Online
Speakers
Speaker's Profile:
Prof Frank E. Harrell, Professor of Biostatistics, Vanderbilt
Frank E. Harrell is a Professor of Biostatistics at Vanderbilt School of Medicine, where he founded the Department of Biostatistics. Prof Frank has been instrumental in several areas of biostatistics including advocating for preserving information contained in data rather than using cut-offs, advocating for the widespread use of semiparametric models, pioneering ideas around prediction modelling, and authoring the influential book Regression Modelling Strategies which is widely used as a standard text for biostatisticians and biostatistics students. He has developed many online resources for clinical trial design and analysis including hbiostat.org/bayes and hbiostat.org/endpoint and has an active blog site at fharrell.com. Prof Harrell was an Expert Advisor to the U.S. FDA from 2016 to 2020 and 2022 to 2026 and has participated in drafting guidance on the use of Bayesian statistics in clinical trials when seeking regulatory approval for new treatments.
