Some operational aspects of the veterans administration cooperative studies program from 1972 to 1979

Abstract

The Cooperative Studies Program of the Veterans Administration Medical Research Service exists to encourage the development and to assist in the conduct and coordination of multicenter clinical trials in the Veterans Administration health care system. The backbone of the Program consists of four statistical and administrative coordinating centers and a clinical research pharmacy coordinating center. During the period 1972–1979 the Program has undergone considerable growth and reorganization. This paper relates some operational aspects and statistics of the Program during this period. Of 128 applications for funds to plan a cooperative study, approximately 75% reached the planning stage, 70% resulted in completed protocols reviewed by a central evaluation committee, 50% were approved and funded, and 45% resulted in a successfully completed study. The typical VA cooperative study is a prospective, fixed sample, randomized, controlled therapeutic trial having two to four treatment arms, three to ten participating centers, 100–600 patients and lastingone to six years. The largest numbers of studies have been conducted in the cardiovascular, psychiatric, and gastrointestinal diseases. Costs of these studies are also considered.