Searching ClinicalTrials.gov did not change the conclusions of a systematic review

Lisa M. Wilson, Ritu Sharma, Sydney M. Dy, Julie M. Waldfogel, Karen A. Robinson

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives We assessed the effect of searching ClinicalTrials.gov on the conclusions of a systematic review. Study Design and Setting We conducted this case study concurrently with a systematic review. We searched ClinicalTrials.gov on March 9, 2016, to identify trial records eligible for inclusion in the review. Two independent reviewers screened ClinicalTrials.gov records. We compared conclusions and strength of evidence grade with and without ClinicalTrials.gov records for 31 comparisons and 2 outcomes. Results We identified 106 trials (53 in the peer-reviewed literature only, 23 in ClinicalTrials.gov only, and 30 in both sources). For one comparison, the addition of results identified through ClinicalTrials.gov reduced the pooled effect size. We found evidence of selective outcome reporting for two comparisons and suspected publication bias for another two comparisons. For all other comparisons, searching ClinicalTrials.gov did not change conclusions or the strength of evidence grading for the two outcomes. Conclusion Our search of ClinicalTrials.gov bolstered suspicions of reporting biases but did not change either the conclusions or the strength of evidence grading. Further research is needed to determine the effect of searching ClinicalTrials.gov on the conclusions of systematic reviews in different topic areas and as the new rules for registration of trial results take effect.

Original languageEnglish (US)
Pages (from-to)127-135
Number of pages9
JournalJournal of Clinical Epidemiology
Volume90
DOIs
StatePublished - Oct 2017

Keywords

  • Case study
  • ClinicalTrials.gov
  • Diabetic peripheral neuropathy
  • Gray literature
  • Strength of evidence grading
  • Systematic review

ASJC Scopus subject areas

  • Epidemiology

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