CRE - 556 Clinical Research Design

This course will describe and review examples of, and engage in, problem-solving for clinical trials at levels of detail and theory that will qualify students to participate in clinical trials research leadership. Fundamentals of clinical trials (e.g. target population, recruitment, randomization, intervention, blinding, outcome ascertainment, statistical design, informed consent and ethical concerns) are addressed in the context of the congruity of clinical trials with other epidemiology research. We go beyond the simple ability to criticize clinical trial manuscripts. Controversies in the conduct and interpretation of clinical trials are addressed in terms of the trade-offs that must be balanced for those to which there are several possible resolutions that are neither ideal nor unacceptable and in terms of insisting on the single correct approach for those to which there is only one acceptable resolution. A primary goal is to integrate principles of biostatistics, ethics, computer science and medical practice. Leading clinical trials experts present examples of their work to the class. Offered: fall. Retake Counts for Credit: No. Credit(s): 3