the database for aggregate analysis of clinicaltrials.gov (aact) and subsequent regrouping by clinical specialty数据库将临床试验的综合分析。.pdf

The Database for Aggregate Analysis of ClinicalT (AACT) and Subsequent Regrouping by Clinical Specialty 1 1 1 1 1 1 Asba Tasneem *, Laura Aberle , Hari Ananth , Swati Chakraborty , Karen Chiswell , Brian J. McCourt , Ricardo Pietrobon1,2 1 Duke Clinical Research Institute, Durham, North Carolina, United States of America, 2 Department of Surgery, Duke University School of Medicine, Durham, North Carolina, United States of America Abstract Background: The ClinicalT registry provides information regarding characteristics of past, current, and planned clinical studies to patients, clinicians, and researchers; in addition, registry data are available for bulk download. However, issues related to data structure, nomenclature, and changes in data collection over time present challenges to the aggregate analysis and interpretation of these data in general and to the analysis of trials according to clinical specialty in particular. Improving usability of these data could enhance the utility of ClinicalT as a research resource. Methods/Principal Results: The purpose of our project was twofold. First, we sought to extend the usability of ClinicalT for research purposes by developing a database for aggregate analysis of ClinicalT (AACT) that contains data from the 96,346 clinical trials registered as of September 27, 2010. Second, we developed and validated a methodology for annotating studies by clinical specialty, using a custom taxonomy employing Medical Subject Heading (MeSH) terms applied by an NLM algorithm, as well as MeSH terms and other disease condition terms provided by study sponsors. Clinical specialists reviewed