Oct 14th 2013

HSPH-HMS214X: Fundamentals of Clinical Trials (edX)

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Clinical trials play a pivotal role in evidence-based medicine. This course will discuss the design, conduct, analysis, and interpretation of Phase I-IV clinical studies.

This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical trials research. Topics include the design, implementation, and analysis of trials, including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III, and Phase IV studies. All aspects of the development of a study protocol will be addressed, including criteria for the selection of participants, treatments, and endpoints, randomization procedures, sample size determination, data analysis, and study interpretation. The ethical issues that arise at each phase of therapy development will be explored.

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