*Note – This is an Archived course*

This is a past/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, but many people enjoy watching the videos and working with the materials. Make sure to check 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.