University of Minnesota

“If It Isn’t Fun.” – The Coronary Drug Project (CDP)

The CDP was the first randomized clinical trial (RCT) in which I was to really “sink my teeth.” The Minnesota Code and the UGDP experience had established our Minnesota role in assessing clinical exclusions, events, and end-points for RCTs. This precipitated my involvement in planning for new trials as they arose, and in their safety and data-monitoring, with exposure to design and decision issues, preparing me, in turn, for the greatly expanded preventive trials and demonstration projects to follow.

The CDP was one of the first major trials of “secondary prevention” with coronary event endpoints, the largest multicenter study with well-conceived design and formal structure, a steering committee of investigators and experts that met regularly, a policy advisory board, a data-monitoring and safety committee, and an independent analysis center, which took responsibility for quality control of procedures. It had the inspired leadership of Jeremiah Stamler, the Maryland Coordinating Center, and Steering members, and expert review groups.

The ongoing management of this team, its attention to detail but also to the long view, its effective conduct of ancillary studies, carried out without jeopardizing the central study and giving recognition and incentive to younger investigators, its rigor and courage in stopping early the treatments deviating from expected, its clear results and conclusions, and effective publications, all provided a superb model, unfortunately one not always followed among subsequent preventive trials. Its relaxed but scholarly and strong leadership and highly functional organization resulted in greater efficacy, more professional satisfaction, and a positive team spirit, none of which should be as rarely found as they are in clinical trials. Useful monographs continued to be published for years from CDP experience.

The most satisfying collaborations of my entire research career were in preparations, presentations, and publications on the prognostic power of the ECG and other characteristics among survivors of myocardial infarction in the CDP, along with Suketami Tominaga, Jerry Stamler, and the Coordinating Center staff.

Click to go onto the next section.