Introduction: A centralized registry of both published and prospective trials is needed to perform systematic reviews of evidence-based research on HIV/AIDS prevention, intervention, and treatment. Published research results can be identified through established bibliographic databases (e.g., MEDL1NE, Embase), in which clinical trials are being systematically coded by the Baltimore Cochrane Center, by indexers, and by authors. Specialized databases have also been developed for systematic reviews, e.g., the U.S. Centers for Disease Control and Prevention's Prevention Research Synthesis (PRS) system and the U.K. Centre for the Evaluation of Health Promotion and Social Interventions (EPIC). No comprehensive register of prospective trials exists for HIV/AIDS or for any other disease, although some limited examples exist for subsets of trials, e.g., PDQ for cancer (NCI-approved trials in the U.S.), ACTIS for HIV/AIDS (PDA-approved trials in the U.S.). International efforts to produce prospective registries (e.g., InterACT) have had little success.

Objective: To assess the feasibility of (l) creating a comprehensive, international registry of prospective trials on HIV/AIDS prevention, intervention, and treatment, and (2) using the HIV/AIDS model to create a Cochrane-wide registry of prospective trials on all diseases and conditions being addressed in Cochrane systematic reviews.

Methods: Existing registries of prospective trials were identified through reviews of the literature and discussions with researchers and reviewers. These include registries for HIV/AIDS, cancer, eye diseases, STD prevention, and cover the U.S., Canada, Europe, and South America. The format of trial records in each registry was analyzed and compared with the minimum field requirements of the Cochrane registry.

Results: A final set of fields was selected, and a record format for a pilot HIV/AIDS registry was developed. This pilot registry will be made available for searching on the website of the HIV/AIDS CRG, and after testing, will be added to the Cochrane library. Similarly, a pilot registry is being developed to include HIV/AIDS, cancer, and infectious diseases.

Discussion: Registries of prospective clinical trials developed for patient accrual, regulatory, and other reasons, are sources of critical research data for Cochrane reviewers and other evidence-based researchers. The trials data can be added to the Cochrane library to assist reviewers in ensuring that their reviews are as comprehensive as possible. Issues such as ongoing identification efforts and maintenance of the registry are challenges that will be addressed as the pilot continues development.