Issues in the Registration of Clinical Trials

• Published in: JAMA : the journal of the American Medical Association Vol. 297; no. 19; pp. 2112 - 2120
• Main Authors: Zarin, Deborah A, Ide, Nicholas C, Tse, Tony, Harlan, William R, West, Joyce C, Lindberg, Donald A. B
• Format: Journal Article
• Language: English
• Published: Chicago, IL American Medical Association 16-05-2007
• Subjects: Biological and medical sciences; Biomedical research; Clinical trials; Clinical Trials as Topic - ethics; Clinical Trials as Topic - standards; Databases, Factual; General aspects; Health care policy; Information Dissemination; Information Storage and Retrieval; Internationality; Medical sciences; National Library of Medicine (U.S.); Registration; Registries - standards; Registries - statistics & numerical data; Research methodology; United States; Websites; United States; Medicine; Drug; Clinical trial
• ISSN: 0098-7484; 1538-3598
• 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.