On December 17, 2019, we released our sixth short video, Dose Selection. This topic is presented by Dr. Barbara Wendelberger of Berry Consultants, LLC.
Proper dosing is a fundamental weakness of modern drug development. Choosing too low a dose and efficacy may not be achieved, while choosing too high a dose can result in safety and tolerability issues. Despite the importance of proper dosing, most development programs make dose decisions on the basis of small, and hence inaccurate, phase 1 and phase 2 trials. In this video Barbara Wendelberger discusses methodologies for improving dose selection in phase 2 and phase 3 drug development. These include dose response modeling (often while including more doses within a study), adaptive randomization across the dose space, and seamless phase 2/3 clinical trials. These methodologies, illustrated in this talk by completed clinical trials, can significantly increase the accuracy of dose selection.
Barbara Wendelberger is a Statistical Scientist at Berry Consultants. She earned her PhD in 2016 from the University of Wisconsin. Previously, Barbara was a member of the Genomics group at Los Alamos National Laboratory, participating in both sequencing technology and metagenomics research.Her research interests continue to focus on data-driven inference at the juncture between statistics, mathematics, biology, and medicine.