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Abstract:
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Have you ever conducted or have thought about a trial that employed Bayesian methods. Bayesian methods offer a valuable chance to advance the development of trials in all phases as they get more complicated and a large amount of relevant data is accumulated. Bayesian analysis naturally facilitates use of sequential experiments potentially allowing for smaller, more informative trials. They are ideally suited for dose-finding studies, pediatric extension trials, modifying interim trial designs, trials requiring historical control, selection of biomarkers from pilot studies, and testing the sensitivity of results in later trial phases. They are being used in the medical device industry for efficacy trials and to address safety concerns in drug industry. Let us discuss the rationale underlying Bayesian trials, their pros and cons, and their applicability to the process of drug development.
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