Early Contributions to the Design and Conduct of Clinical Trials From a Largely Unknown 1960s Pilot Trial of Physical Activity and a Well-Known Diet-Heart Feasibility Study for the Primary Prevention of Coronary Heart Disease.

Abstract

This historical note focuses on contributions to the concepts, design, methods, and conduct of clinical trials from the 1960s planning and findings of a feasibility study that was little reported and largely unrecognized: the Pilot Study of Prescribed Physical Activity for the Primary Prevention of Ischemic Heart Disease (1963-1968). In contrast, complementary findings from the 1960s National Diet-Heart Feasibility Study (1962-1968) were fully reported, widely recognized, and well-analyzed by historians in context of the rapid evolution in chronic disease epidemiology and clinical trials following World War II. The experience of these thoughtfully planned and rigorously conducted pilot studies changed the career paths of their planners and investigators and shaped the form and direction of subsequent research on the causes, treatment, and prevention of heart attack. The 2 studies were both fruit and seed of a consortium of experts that evolved in reaction to new questions and findings about the midcentury coronary disease epidemic. The contributions of each study, and of this broader academy of pioneer thinkers, are essential elements in the history of cardiovascular disease epidemiology, prevention research, and health policy.