The goal of this class is to present an introduction to the practical aspects involved in the design and analysis of clinical trials.  It describes logistical issues, basic principles, and philosophy alongside necessary methodology.  Students will learn the role of clinical trials in medical research, beginning with algorithmic and Bayesian dose finding (phase I) trials and then preliminary (phase II) and confirmatory (phase III) studies of efficacy.  The need for blinding and various types of randomization and stratification will be presented. Methods of early stopping and design modification at interim analyses via group sequential and other adaptive designs will then be discussed, proceeding to techniques for analyzing studies with continuous, binary, longitudinal, quality of life, and survival data [see comment above for which topics you need here].  Design and analysis principles will be discussed for various study types including crossover, n-of-1, factorial, non-inferiority, randomized discontinuation, and multi-stage trials along with recent innovations such as umbrella and basket trials.  The course will also present various computational tools and web-based applications useful in implementing the above objectives.  At its end students will be able to be usefully employed in the design and analysis of clinical trials in the pharmaceutical industry and academia.

Continuous Assessment: 60%

Examination: 40%

Examination Duration: 3 hours