In the third and final session of the NC TraCS Biostatistics Fall 2020 Seminar series, we consider the problem of Bayesian sample size determination for a clinical trial in the presence of historical data that inform the treatment effect. Our broadly applicable, simulation-based methodology provides a framework for calibrating the informativeness of a prior while simultaneously identifying the minimum sample size required for a new trial such that the overall design has appropriate power to detect a non-null treatment effect and reasonable type I error control. We demonstrate our methodology using a real data set to design a follow-up clinical trial with time-to-event endpoint for an investigational treatment in high-risk melanoma.
Presenter
Joeseph Ibrahim, PhD
UNC Department of Biostatistics
The NC TraCS Biostatistics Seminar Series provides more in-depth discussion of select biostatistical topics for clinical and translational researchers who have basic quantitative training in biostatistical methods. Join us this fall for seminars on data visualization & statistical graphics, power analysis & sample size planning, and Bayesian clinical trial design.