Abstract

The objective of our course is to provide a general understanding of statistical reasoning, an appreciation of the statistician's role in drug development, and to facilitate effective communication between statisticians and clinical researchers. Brief lectures are followed immediately by interactive workshops which reinforce statistical concepts. Major subject areas include study design, data handling, data analysis, and interpretation of results. Specific topics include bias, sample size, data collection, descriptive statistics, and basic statistical methods. One continuing workshop requires students to create a protocol and then to analyze, interpret, and present data “collected” by course staff. Other workshops exhibit concepts of random sampling and making decisions with uncertainty. Student learning and course acceptability are greatly enhanced by discussions generated by the workshops, breaking the class into small study groups during the workshops, and the personalized attention that students recei...

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