Special Communication
May 16, 2007

Issues in the Registration of Clinical Trials

Author Affiliations

Author Affiliations: National Library of Medicine (NLM) (Drs Zarin and Lindberg) and Office of Biotechnology Activities (Dr Tse), National Institutes of Health, US Department of Health and Human Services, Bethesda, Md; and American Psychiatric Institute for Research and Education, Arlington, Va (Dr West). Mr Ide is a contractor with Thoughtful Solutions Inc, McLean, Va, through which he works full time with the NLM. Dr Harlan is a self-employed contractor to the NLM. Dr Zarin was formerly at the Technology Assessment Program at the Agency for Healthcare Research and Quality. Dr Tse was formerly a staff scientist at the NLM.

JAMA. 2007;297(19):2112-2120. doi:10.1001/jama.297.19.2112

Public concerns about the perils associated with incomplete or delayed reporting of results from clinical trials has heightened interest in trial registries and results databases. Here we review the current status of trial registration efforts and the challenges in developing a comprehensive system of trial registration and reporting of results. ClinicalTrials.gov, the largest trial registry with 36 249 trials from approximately 140 countries, has procedures in place to help ensure that records are valid and informative. Key challenges include the need to minimize inadvertent duplicate registrations, to ensure that interventions have unambiguous names, and to have a search engine that identifies all trials that meet a user's specifications. Recent policy initiatives have called for the development of a database of trial results. Several issues confound the implementation of such a database, including the lack of an accepted format or process for providing summaries of trial results to the public and concerns about disseminating data in the absence of independent scientific review.