Update on Trial Registration 11 Years after the ICMJE Policy Was Established

Abstract

Laws and policies to establish a global trial reporting system have greatly increased the transparency and accountability of the clinical research enterprise. The three components of the trial reporting system are trial registration, reporting of aggregate results, and sharing of individual participant data. 1 Trial registration is founda-tional to our understanding and interpretation of trial results, because it requires that information be provided about all relevant clinical trials (to put results in a broad context) and their pre-specified protocol details (to ensure adherence to the scientific plan). In this article, we describe the current trial registration landscape and summarize evidence of its effect on the clinical research enterprise to date. We then present the results of analyses that were performed with the use of ClinicalTrials.gov data to provide additional evidence regarding the degree to which current practices are fulfilling certain key goals initially envisioned for trial registration. Finally, we identify challenges and suggest potential responses for the next decade. Ke y Goal s of Trial Regis tr ation in the Trial Rep or ting S ys tem Trial registration involves the submission of descriptive information about a clinical trial to a publicly accessible, Web-based registry. Two key goals underlie the registration requirements. The first goal is to establish a publicly accessible and searchable database for disseminating a minimum set of structured information about all ongoing and completed trials. Trial registries are designed to publicly document all biomedi-cal or health-related experiments involving humans , facilitate the identification of trials for potential participants, and permit the incorporation of clinical research findings into the medical evidence base. The second goal is to provide access to date-stamped protocol amendments that occur during the trial. Access to structured archival information allows the public to track the progress of individual studies and assess whether reported results are consistent with the prespecified protocol or statistical analysis plan.