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The Quality of Registration of Clinical Trials

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  • Roderik F Viergever
  • Davina Ghersi

Abstract

Background: Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials. Methods and Findings: A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame. Conclusions: Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records.

Suggested Citation

  • Roderik F Viergever & Davina Ghersi, 2011. "The Quality of Registration of Clinical Trials," PLOS ONE, Public Library of Science, vol. 6(2), pages 1-8, February.
    • Handle: RePEc:plo:pone00:0014701
    DOI: 10.1371/journal.pone.0014701
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    References listed on IDEAS

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    1. Kerry Dwan & Douglas G Altman & Juan A Arnaiz & Jill Bloom & An-Wen Chan & Eugenia Cronin & Evelyne Decullier & Philippa J Easterbrook & Erik Von Elm & Carrol Gamble & Davina Ghersi & John P A Ioannid, 2008. "Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias," PLOS ONE, Public Library of Science, vol. 3(8), pages 1-31, August.
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    1. Thomas M Schindler & Frank Grieger & Anna Zak & Ramona Rorig & Kavya Chowdary Konka & Anna Ellsworth & Christopher Pfitzer & Keir Hodge & Christine Crandall & on behalf of the TransCelerate Clinical R, 2020. "Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields," PLOS ONE, Public Library of Science, vol. 15(5), pages 1-15, May.
    2. Wei-Yen Hsu, 2012. "Registration Accuracy and Quality of Real-Life Images," PLOS ONE, Public Library of Science, vol. 7(7), pages 1-13, July.
    3. Wei-Yen Hsu, 2013. "A Practical Approach Based on Analytic Deformable Algorithm for Scenic Image Registration," PLOS ONE, Public Library of Science, vol. 8(6), pages 1-10, June.
    4. Wynanda A van Enst & Rob J P M Scholten & Lotty Hooft, 2012. "Identification of Additional Trials in Prospective Trial Registers for Cochrane Systematic Reviews," PLOS ONE, Public Library of Science, vol. 7(8), pages 1-5, August.

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