The Coronary Drug Project. Role of the National Institutes of Health

A clinical trials staff within an Institute is essential for adequate participation in and monitoring of any large cooperative clinical trial supported by that Institute. At minimum such a staff should consist of a medical scientist with professional interests and experience in clinical trials methodology; a biometrician with direct experience and interest in the design, large-scale data collection, data analysis, and quality control needs of such trials; a contract specialist; and additional consultants in the technical areas related to the clinical disease or intervention study, such as pharmacology, laboratory operations, computer science, or other areas. The continuity of professional development and experience of such a staff is essential to expand the capabilities for participation and advancement of this rapidly developing science of the design, organization, and conduct of cooperative clinical trials.