Fundamentals of Clinical Trials

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. This course contains 12 modules. The modules will be released Monday of each week, with the exception of some holiday weeks. Most students should plan to spend 4 – 6 hours on each module. Students will have until February 14, 2014 to earn a HarvardX certificate. Before your course starts, try the new edX Demo where you can explore the fun, interactive learning environment and virtual labs. Learn more. HarvardX requires individuals who enroll in its courses on edX to abide by the terms of the edX honor code : https://www.edx.org/edx–terms–service. HarvardX will take appropriate corrective action in response to violations of the edX honor code, which may include dismissal from …