Abstract

The evolution of the CDP from its origin in 1960 to its completion in 1975 has been recounted. The inextricable interrelationship of the scientific planning and conduct of this trial with the budgetary considerations and uncertainties as it proceeded are described to illustrate some of the dynamic forces that determine whether or not such large-scale trials can be brought to successful completion. A clear message from this experience is that a long-term clinical trial needs full advance scientific and administrative discussion and an understanding of the resources required to bring it to its completion. Continuing scientific and administrative commitment are also essential to assure that the needed resources are provided over the course of the trial. The experience gained n this long-term clinical trial involving 53 clinics, a Coordinating Center, Central Laboratory, ECG Reading Center, and Drug Procurement and Distribution Center has provided a basic model for the new generation of clinical trials that have since been undertaken by the NHLBI.

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