CE_16C: Practical Considerations for Bayesian and Frequentist Adaptive Clinical Trials (Added Fee)

Clinical trials play a critical role in drug development. New trial designs often depend on historical data, which, however, may not be accurate for the current study due to changes in study populations, patient heterogeneity, or different medical facilities. Consequently, the original study design may need to be adjusted or even altered to accommodate new findings and unexpected interim results. Through carefully thought-out and planned adaptation, the right dose can be identified faster, patients can be treated more effectively, and treatment effects evaluated more efficiently. Reflecting the increasing importance and use of adaptive clinical trials, the International Council for Harmonisation (ICH) has recently tasked a working group to develop harmonized regulatory guidance for these studies in global drug development programs. This one-day short course introduces various adaptive methods for Phase I to Phase III clinical trials using both, frequentist and Bayesian methods. Accordingly, 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 and dose insertion designs, adaptive dose finding studies, trials with blinded and unblinded sample size re-estimation as well as adaptive designs for confirmatory trials with treatment or population selection at interim.