3.0

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Augments Introduction to Clinical Trials (340.645). Describes current standards for clinical trial protocols, consent procedures and describes regulatory requirements and expands upon design and analysis concepts presented in 340.645. Reviews key standards for clinical trial protocols, including the SPIRIT guidelines, recruitment and consent of participants, and principles for data acquisition and sharing. Covers regulatory requirements for drug development and adverse event monitoring as well as the statistical aspects of data monitoring for clinical trials. Provides more in-depth discussion of newer designs for clinical trials including non-inferiority design and adaptive designs. Investigates specific analysis issues for handling missing data, interim monitoring and cost-effectiveness. Addresses the synthesis of results from clinical trials in meta-analyses and the role of post-marketing surveillance in assessing drug safety.