Abstract

Each day, patients and their physicians make treatment decisions with access to only a fraction of the relevant clinical research data. Many clinical studies, including randomized clinical trials, are never published in the biomedical literature.1,2 Among those that are published, key information is often not presented, such as data on specific outcomes and safety endpoints.3,4 Moreover, patient-level data from clinical trials are rarely available, leaving investigators to conduct meta-analyses of summary-level data, an approach with limitations.5 Current clinical research standards lack sufficiently strong requirements for transparency and availability. There are no uniform international standards requiring that study protocols, statistical analysis plans, and study results be made available, nor that completed clinical trial data be posted for independent analysis. Even data submitted to the U.S. Food and Drug Administration are not made publicly available.

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