The ClinicalTrials.gov Results Database--Update and Key Issues

N Engl J Med. 2011 Mar 3;364(9):852-60. doi: 10.1056/NEJMsa1012065.

Abstract

Background: The ClinicalTrials.gov 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.

Methods: We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010.

Results: As of September 27, 2010, ClinicalTrials.gov 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.

Conclusions: ClinicalTrials.gov 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.

MeSH terms

  • Clinical Trials as Topic* / legislation & jurisprudence
  • Clinical Trials as Topic* / standards
  • Databases, Factual* / statistics & numerical data
  • Government Regulation
  • Information Dissemination
  • National Library of Medicine (U.S.)
  • Outcome Assessment, Health Care / standards
  • Public Policy
  • Quality Control
  • Registries* / statistics & numerical data
  • United States
  • United States Food and Drug Administration