*Note: This is an Archived course. At this time, you can only explore this course in a self-paced fashion. Certain features of this course may not be active (i.e. discussion forum), but many people enjoy watching the videos and working with the materials. Make sure to check back for reruns of this course.

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.

Meet The Faculty

James Ware

James Ware

Professor Ware's research focuses on methods for the analysis of longitudinal data and on the design and analysis of clinical trials. He has served as senior statistician for randomized trials of strategies for protecting the brain during surgical repair of transposition of the great arteries in infants, chelation therapy for lead-exposed children and, currently, vitamin D supplementation to prevent development of diabetes. He has been a statistical consultant to the New England Journal of Medicine since 1990.

Dr. Ware has taught on clinical trials (BIO214) for many years at the Harvard T.H. Chan School of Public Health. He has also been involved in the development of masters degree programs in epidemiology and biostatistics with international partners in Cyprus and Saudi Arabia.

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