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Published on Dec 29, 2011
Presented by Dr. Brent Logan, PhD, Professor in the Division of Biostatistics, Medical College of Wisconsin. This lecture will provide an overview of study designs and statistical issues in all phases of clinical trials. We will start by describing dose-finding phase I designs, and then will cover phase II designs, including the framework for determining sample size and the use of two-stage designs. The remainder of the lecture will focus on major design issues in phase III clinical trials, including endpoint specification, eligibility, power and sample size calculation, blinding, randomization, stratification, and data monitoring.