As part of a project that examined the degree to which sponsors of clinical research are complying with federal requirements for the reporting of clinical trial results, the Clinical Trials Transformation Initiative (CTTI) and the authors of the study are making the primary datasets used in the analysis available to the public.
The analysis, the results of which were published in the New England Journal of Medicine, found that the results of many trials subject to reporting requirements mandated in the Food and Drug Administration Amendments Act (FDAAA) were not being provided to the ClinicalTrials.gov registry in a timely fashion.
The analysis datasets used in the study are now available from the CTTI website at the location below:
Please note: the link opens a Microsoft Excel file. The first worksheet provides descriptions and a data dictionary. The second worksheet contains all data and variables used in the analysis.
Additional resources for examining data from ClinicalTrials.gov are also available from CTTI at their "State of Clinical Trials" page.