Cost and efficiency in clinical trials: the U.S. Physicians' Health Study.
The U.S. Physicians' Health Study, a primary prevention trial of low-dose aspirin in the reduction of cardiovascular disease and of beta-carotene in lowering cancer risk, implemented a number of design strategies to decrease costs and increase efficiency. These included the choice of physicians as the study population, use of a factorial design, implementation of a pre-randomization run-in phase, and the collection of pre-randomization blood specimens. The use of these strategies enabled us to enroll 22,071 subjects and maintain high compliance and long-term follow-up at a fraction of the usual cost of large-scale trials of primary prevention.
Buring
J E
JE
Channing Laboratory, Department of Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts.
Hennekens
C H
CH
D001241:Aspirin / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000517:prevention & control; D002338:Carotenoids / Q000627:therapeutic use; D003365:Costs and Cost Analysis; D004526:Efficiency; D005163:Factor Analysis, Statistical; D006801:Humans; D009369:Neoplasms / Q000517:prevention & control; D010820:Physicians; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic / Q000191:economics* / Q000379:methods; D014481:United States; D019207:beta Carotene
D019207:beta Carotene; D002338:Carotenoids; D001241:Aspirin