BIOSTATISTICS SEMINAR SERIES
Speaker: Robert Makuch, Ph.D.
Professor of Biostatistics, Yale University
Title: Treatment Effects Assessment in Multi-Regional Clinical Trials (MRCTs) Using Bayesian Methods
Abstract: Multi-regional clinical trials (MRCTs) help to synchronize drug development globally, whereby the time lag in marketing authorization among different countries is minimized. However, there are statistical concerns associated with analysis and interpretation of MRCTs. The results of certain countries/regions could vary significantly from the overall results. In this case, controversy exists regarding the extent to which country-specific result should be minimized/ignored and medical scientists/regulators should defer to the overall global treatment effect. Rather than analyzing data separately in each region, our discussion today focuses on developing a Bayesian framework for assessing heterogeneity of regional treatment effects that leverages data collected in other regions. The goal is to make scientifically valid judgements about the play of chance versus real regional differences when comparing results to the overall trial outcome.
Bio3 Seminar Series sponsored by
Department of Biostatistics, Bioinformatics & Biomathematics (DBBB)
Friday, October 11 at 10:00am to 11:00am
New Research Building, Auditorium
3800 Reservoir Road, N.W., Washington