Lynn A. Sleeper, Harvard Medical School/Boston Children’s Hospital, Dept of Cardiology
Description of Workshop
This course will provide an overview of Data Monitoring Committees (DMCs) functions and elaborate on the roles and responsibilities of each specific DMC member. Guidance for interpretation of all aspects of a DMC report will be provided, with actual examples of innovative approaches for clinical trial data related to quality, completeness, and interim findings, with the goal of having attendees learn how to responsibly monitor clinical studies and/or prepare a comprehensive report that will allow a DMC to perform their duties effectively. Course material will also include discussion of the pros and cons of masking and examples of interim monitoring from actual completed studies, with interactive discussion regarding decision-making with respect to early termination. This course may be of particular interest to those from developing countries and any location where clinical research, particularly multicenter research, is becoming more common and there is a recognised need to build capacity with respect to effective monitoring of research.
The goals of the workshop include clarifying the difference between an Institutional Review Board and a Data Monitoring Committee (DMC); to understand the roles and responsibilities of each member of a DMC, and how a DMC operates; to become familiar with the components of a DMC report, learn how to interpret its contents to identify potential concerns with trial conduct and study data, and how to ask the right questions.
Participants will examine some real-life examples of interim monitoring of clinical trials, with emphasis on multiregional trials, and interactively consider different pathways of decision-making for early trial termination.
This course is intended for clinical investigators and statisticians who might serve on a Data Monitoring Committee and be faced with decisions on trial conduct and continuation. Participants working on a clinical study that has a Data Monitoring Committee, and who wish to learn how to construct a comprehensive DMC report will also benefit from this workshop.