Practical Considerations for Bayesian and Frequentist Adaptive Clinical Trials (ADDED FEE) — Professional Development Continuing Education Course
ASA, Section on Bayesian Statistical Science
Clinical trials play a critical role in pharmaceutical 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. As a result, the original plan and 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.
This one-day short course will introduce various adaptive methods for Phase I to Phase III clinical trials using both, frequentist and Bayesian methods. Accordingly, different types of adaptive designs will be introduced and practical considerations will be illustrated with case studies. Types of adaptive clinical trial designs covered in this course include dose escalation/de-escalation and dose insertion based on observed data, adaptive dose finding studies using optimal designs to allocate new cohorts of patients based on the accumulated evidence, blinded and unblinded sample size reestimation as well as adaptive designs for confirmatory trials with treatment or population selection at interim.
Instructor(s): Peter Müller, University of Texas Austin; Byron Jones, Novartis Pharma AG; Frank Bretz, Novartis Pharma AG