Practical Considerations for Adaptive Clinical Trials Using Bayesian and Frequentist Methods

Music City Center 

Room: CC-108 

The planning of a new clinical trial typically depends on historical data, which, however, may not be accurate for the current trial due to changes in study populations, patient heterogeneity, or evolving medical standards. Adaptive designs provide flexibility through the ability to safeguard against inaccurate assumptions at the trial planning stage by taking advantage of the accumulating information from patients and allowing modifications to design aspects during an ongoing trial. Through carefully planned adaptations, the right dose can be identified faster, patients can be treated more effectively, and treatment effects evaluated more efficiently. Reflecting the increasing use of adaptive clinical trials, the International Council for Harmonisation (ICH) has tasked a working group to develop harmonized regulatory guidance that is expected to be released for public consultation by the time of this course.

This one-day short course introduces adaptive designs for Phase I to Phase III
clinical trials using Bayesian and frequentist methods. We introduce different types of adaptive designs and illustrate practical considerations with case studies. Types of adaptive designs covered in this course include dose escalation/de-escalation, master protocol designs, adaptive dose-finding studies, as well as adaptive designs for confirmatory trials with treatment or population selection at interim.

Section on Bayesian Statistical Science