This module has two key segments. In the morning, two topics will be discussed that have broad implications in the design and analysis of clinical trials: the role of biomarkers as replacement (i.e., surrogate) endpoints, and the interpretability of confirmatory vs. exploratory analyses. In the afternoon, attention will be given to a topic having broad implications in the conduct of clinical trials: the role of Data Monitoring Committees and current challenges in their implementation. 

Course materials. To get the most out of this module, participants are encouraged to acquire a copy of the 2^nd edition, “Data Monitoring Committees in Clinical Trials: A Practical Perspective” by Susan Ellenberg, Thomas R. Fleming, and David L. DeMets, and have it on hand during the course. Note the 1^st edition is not a sufficient resource for this module; only the 2^nd edition.