The Role of General Clinical Research Centers in Clinical Trials
A Characterization with Recommendations
Reports the results of the second year of a two-year project to evaluate the role of NIH-supported General Clinical Research Centers (GCRCs) in clinical trials, with emphasis on information processing. GCRCs provide personnel and facility resources to support clinical research (including trials). Based on interviews with about 130 investigators and 75 support staff members, the authors recommended that the GCRCs should provide research data coordinators to support clinical trials; make biomedical scientists available in the GCRCs on a regular but limited consulting basis; augment the functional capabilities of the CLINFO data management and analysis system to include analysis of covariance, improved data editing, document tracking, sample size determination and randomization; provide a computerized nutrient database and diet calculation program for GCRC dietitians; provide fiscal management and word processing computer programs for GCRC administrative coordinators; and explore methods to help investigators increase their expertise in research methodology, statistics, and information processing.