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ClinicalTrials.gov: A Report to the Board of Scientific Counselors
We present a conceptual framework of clinical trial registries that describes five primary purposes of registries cited in the literature and the data elements required for each. Next, the scope of the registries is discussed in the context of types of clinical research studies and sponsors, as called for by various policy initiatives. Incorporation of the ICMJE criteria illustrates the most recent expansion of ClinicalTrials.gov to accommodate a rapidly changing environment. The challenges of assuring data quality on information provided to ClinicalTrials.gov by external sources are discussed. The implementation of the ClinicalTrials.gov system is then described along with its context within the Lister Hill National Center for Biomedical Communications. Future challenges include developing mechanisms to improve registration rates, ensuring the accuracy of information submitted to ClinicalTrials.gov, and evaluating the overall effectiveness of the site.