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Research methods
Research
Discrepancies between ClinicalTrials.gov recruitment status and actual trial status: a cross-sectional analysis
  1. Christopher W Jones1,
  2. Michelle R Safferman1,
  3. Amanda C Adams2,
  4. Timothy F Platts-Mills3
  1. 1 Department of Emergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA
  2. 2 Medical Library, Cooper Medical School of Rowan University, Camden, New Jersey, USA
  3. 3 Department of Emergency Medicine, University of North Carolina, Chapel Hill, North Carolina, USA
  1. Correspondence to Dr Christopher W Jones; jones-christopher{at}cooperhealth.edu

Abstract

Objectives To determine the accuracy of the recruitment status listed on ClinicalTrials.gov as compared with the actual trial status.

Design Cross-sectional analysis.

Setting Random sample of interventional phase 2–4 clinical trials registered between 2010 and 2012 on ClinicalTrials.gov.

Primary outcome measure For each trial which was listed within ClinicalTrials.gov as ongoing, two investigators performed a comprehensive literature search for evidence that the trial had actually been completed. For each trial listed as completed or terminated early by ClinicalTrials.gov, we compared the date that the trial was actually concluded with the date the registry was updated to reflect the study’s conclusion status.

Results Among the 405 included trials, 92 had a registry status indicating that study activity was either ongoing or the recruitment status was unknown. Of these, published results were available for 34 (37%). Among the 313 concluded trials, the median delay between study completion and a registry update reflecting that the study had ended was 141 days (IQR 48–419), with delays of over 1 year present for 29%. In total, 125 trials (31%) either had a listed recruitment status which was incorrect or had a delay of more than 1 year between the time the study was concluded and the time the registry recruitment status was updated.

Conclusions At present, registry recruitment status information in ClinicalTrials.gov is often outdated or wrong. This inaccuracy has implications for the ability of researchers to identify completed trials and accurately characterise all available medical knowledge on a given subject.

  • epidemiology
  • World Wide Web technology
  • trial registration
  • ClinicalTrials.gov

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-017719

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    Footnotes

    • Contributors CJ conceived the study. CJ, MS, AA and TFPM all contributed to the study design. CJ, MS and AA performed data collection. CJ performed data analysis and interpretation and drafted the article. All authors provided critical revisions to the article, and read and approved the final manuscript.

    • Competing interests CJ is an investigator on unrelated studies sponsored by AstraZeneca, Roche Diagnostics, Inc, and Janssen, for which his department received research grants. The remaining authors declare no additional competing interests.

    • Patient consent Not obtained.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement The full data set is available from the corresponding author on reasonable request.