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Activity Details

CE_08C Sun, 8/3/2014, 8:30 AM - 5:00 PM CC-160B
Adaptive Methods in Modern Clinical Trials — Professional Development Continuing Education Course
ASA , Biometrics Section
Clinical trials play a critical role in pharmaceutical drug development. Often the original plan and study design may need to be adjusted or even altered to accommodate new findings and unexpected interim results. The goal of using adaptive methods in clinical trials is to enhance the flexibility of trial conduct as well as maintain the integrity of trial findings. Through carefully thought out and planned adaptation, we can pinpoint the right dose faster, treat patients more effectively, identify treatment effects more efficiently, and thus expedite the drug development process. From the perspective of practicality, we will provide an overview of various adaptive methods for Phase I to Phase III clinical trials. Different types of adaptive designs will be introduced and illustrated with case studies, including dose escalation/de-escalation, adaptive dose finding using optimal designs to allocate new cohorts of patients based on the accumulated evidence, population enrichment designs, early stopping for toxicity, futility, or efficacy using group-sequential designs, blinded and un-blinded sample size re-estimation as well as adaptions in confirmatory trials with treatment or population selection at an interim stage. The difficulty is at a second-year graduate course level. Prerequisite knowledge includes basic Bayesian inference, likelihood methods, hypothesis testing, and R programming.
Instructor(s): Frank Bretz, Novartis, Byron Jones, Novartis, Guosheng Yin, University of Hong Kong

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