The Results Database - Update and Key Issues

Lister Hill National Center for Biomedical Communications, National Library of Medicine, National Institutes of Health, Bethesda, MD 20894, USA.
New England Journal of Medicine (Impact Factor: 55.87). 03/2011; 364(9):852-60. DOI: 10.1056/NEJMsa1012065
Source: PubMed


The trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research.
We analyzed data that were publicly available between September 2009 and September 2010.
As of September 27, 2010, received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data.

    • "Further, a review of the results from published trials that were registered in suggests that most deviated from the preregistered plan of analysis in metric, method of aggregation, or timing of primary outcome measures employed, and the majority of studies (69%) failed to include all participants in the final published analyses (Zarin et al., 2011). No study has explicitly examined discrepancies from trial registration in reporting alcohol treatment trials, but it is likely to be similarly problematic. "
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    • "Analysis and clustering of transcription factor binding site profiles is performed with the use of JASPAR (Bryne et al., 2008), and access to orthology information and clinical trials is given by the ENSEMBL (Vilella et al., 2009) and (Zarin et al., 2011) resources, respectively. Finally, patent information is collected from the EPO Proteins (, "
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    • "database by the NIH. The creation of this database is itself part of policy initiatives aiming at regulating the controversial domain of clinical research, marred by accusations of conflicts of interest, publication bias, etc. Unsurprisingly, the database itself has run into trouble, due to criticism about its incomplete coverage, failure to include relevant information, and lack of standardization, which in turn has led to additional policy initiatives (compulsory registration of trials if results are to be published, etc.) (Zarin et al. 2011). In spite of all these problems that complicate its appropriation for our own purposes, the database offers the advantage of assembling in a single virtual space entities such as clinical researchers, molecules (drugs), the institutions performing the trial, public organizations (oncology networks), commercial organizations (pharmaceutical and biotech companies), diseases, technologies, and publications. "
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