A clinic's perspective on screening, recruitment and data collection

This paper summarizes the approach of one university cardiology section with over a decade of experience in conducting National Institutes of Health and pharmaceutical cardiovascular trials. Many of the organizational and personnel issues discussed can be directly applied to most university cardiovascular clinical research settings. Other aspects reflect a very specialized approach but key features can be modified or adapted to smaller individual research clinics. In terms of organizational features, our multi-hospital recruitment effort is co-ordinated by a weekly clinical research conference which is attended by all nurse co-ordinators and cardiology fellows. Centralization of all clinic facilities and non-invasive laboratories, the central computer facility, and the availability of clinical research inpatient hospital beds facilitate our clinical research effort. An expanded role of the nurse co-ordinator is considered pivotal to trial performance. Suggestions are made as to the identification and recruitment of ideal nurse co-ordinators, maximizing their productivity, and retaining them. The key feature is the physicians' acceptance of the nurse co-ordinator as a colleague. The roles of the principal investigator and clinical cardiology fellows are delineated, and suggestions made for data entry and computer technical expertise to optimize nurse co-ordinator efficiency, allowing total focus on recruitment and follow-up.