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

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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 foundational 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 prespecified 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.