-ctgov-: A suite of Stata commands for reporting trial results to ClinicalTrials.gov

Phil Schumm (pschumm@uchicago.edu) and Theodore Karrison
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Phil Schumm: Department of Health Studies, University of Chicago
Theodore Karrison: Department of Health Studies, University of Chicago

2014 Stata Conference from Stata Users Group

Abstract: In response to the 1997 Food and Drug Administration Modernization Act (FDAMA), the National Institutes of Health (NIH) established ClinicalTrials.gov, an online, publicly-accessible registry for clinical trials. The 2007 Food and Drug Administration Amendments Act (FDAAA) broadened the scope of eligible trials, added outcomes reporting as a requirement, and established penalties for non-compliance. Although ClinicalTrials.gov increased the transparency with which clinical trials are conducted in the U.S. and opened up new possibilities for research using the information collected, additional resources, time and effort are required to comply with this mandate. This presentation will introduce -ctgov-, a suite of Stata commands to facilitate the reporting of trial results. By using this tool, researchers will be able to generate results for automatic upload to ClinicalTrials.gov at the same time they are doing their primary analyses, thereby eliminating much of the additional effort and ensuring that the results in ClinicalTrials.gov match those in the official publication or report. Although primarily of interest to clinical researchers, biostatisticians and pharmaceutical companies, the approach taken by -ctgov- also has connections to work being done in the area of reproducible research.

Date: 2014-08-02
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