IDEAS home Printed from https://ideas.repec.org/a/plo/pmed00/1000144.html
   My bibliography  Save this article

Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis

Author

Listed:
  • Joseph S Ross
  • Gregory K Mulvey
  • Elizabeth M Hines
  • Steven E Nissen
  • Harlan M Krumholz

Abstract

Joseph Ross and colleagues examine publication rates of clinical trials and find low rates of publication even following registration in Clinicaltrials.gov.Background: ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication. Methods and Findings: We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515), nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46%) of trials were published, among which 96 (31%) provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357) were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p

Suggested Citation

  • Joseph S Ross & Gregory K Mulvey & Elizabeth M Hines & Steven E Nissen & Harlan M Krumholz, 2009. "Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis," PLOS Medicine, Public Library of Science, vol. 6(9), pages 1-9, September.
    • Handle: RePEc:plo:pmed00:1000144
    DOI: 10.1371/journal.pmed.1000144
    as

    Download full text from publisher

    File URL: https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000144
    Download Restriction: no
    File URL: https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1000144&type=printable
    Download Restriction: no
    File URL: https://libkey.io/10.1371/journal.pmed.1000144?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    References listed on IDEAS

    as
    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.
    2. Kristin Rising & Peter Bacchetti & Lisa Bero, 2008. "Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation," PLOS Medicine, Public Library of Science, vol. 5(11), pages 1-10, November.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. The PLoS Medicine Editors, 2011. "Best Practice in Systematic Reviews: The Importance of Protocols and Registration," PLOS Medicine, Public Library of Science, vol. 8(2), pages 1-2, February.
    2. Liu Xuemei & Li Youping & Yin Senlin & Song Shangqi, 2010. "Result Publication of Chinese Trials in World Health Organization Primary Registries," PLOS ONE, Public Library of Science, vol. 5(9), pages 1-7, September.
    3. Diana de la Iglesia & Miguel García-Remesal & Alberto Anguita & Miguel Muñoz-Mármol & Casimir Kulikowski & Víctor Maojo, 2014. "A Machine Learning Approach to Identify Clinical Trials Involving Nanodrugs and Nanodevices from ClinicalTrials.gov," PLOS ONE, Public Library of Science, vol. 9(10), pages 1-15, October.
    4. The PLoS Medicine Editors, 2009. "Ensuring Integrity in Comparative Effectiveness Research: Accentuate the Negative," PLOS Medicine, Public Library of Science, vol. 6(9), pages 1-2, September.
    5. Sylvain Mathieu & An-Wen Chan & Philippe Ravaud, 2013. "Use of Trial Register Information during the Peer Review Process," PLOS ONE, Public Library of Science, vol. 8(4), pages 1-4, April.
    6. Roberta W Scherer & Pamela C Sieving & Ann-Margret Ervin & Kay Dickersin, 2012. "Can We Depend on Investigators to Identify and Register Randomized Controlled Trials?," PLOS ONE, Public Library of Science, vol. 7(9), pages 1-6, September.
    7. Hiroki Saito & Christopher J Gill, 2014. "How Frequently Do the Results from Completed US Clinical Trials Enter the Public Domain? - A Statistical Analysis of the ClinicalTrials.gov Database," PLOS ONE, Public Library of Science, vol. 9(7), pages 1-9, July.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Arnaud Vaganay, 2016. "Outcome Reporting Bias in Government-Sponsored Policy Evaluations: A Qualitative Content Analysis of 13 Studies," PLOS ONE, Public Library of Science, vol. 11(9), pages 1-21, September.
    2. An-Wen Chan, 2008. "Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results," PLOS Medicine, Public Library of Science, vol. 5(11), pages 1-3, November.
    3. Schaub, Jason & Stander, Willem J. & Montgomery, Paul, 2022. "LGBTQ+ Young People’s Health and Well-being Experiences in Out-of-home Social Care: A scoping review," Children and Youth Services Review, Elsevier, vol. 143(C).
    4. Paolo Crosetto & Antonio Filippin & Janna Heider, 2015. "A Study of Outcome Reporting Bias Using Gender Differences in Risk Attitudes," CESifo Economic Studies, CESifo Group, vol. 61(1), pages 239-262.
    5. Nikolaos Pandis & Padhraig S Fleming & Helen Worthington & Kerry Dwan & Georgia Salanti, 2015. "Discrepancies in Outcome Reporting Exist Between Protocols and Published Oral Health Cochrane Systematic Reviews," PLOS ONE, Public Library of Science, vol. 10(9), pages 1-10, September.
    6. 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.
    7. Ewelina Rogozińska & Elizabeth Gargon & Rocío Olmedo-Requena & Amani Asour & Natalie A M Cooper & Claire L Vale & Janneke van’t Hooft, 2020. "Methods used to assess outcome consistency in clinical studies: A literature-based evaluation," PLOS ONE, Public Library of Science, vol. 15(7), pages 1-12, July.
    8. Elizabeth Gargon & Binu Gurung & Nancy Medley & Doug G Altman & Jane M Blazeby & Mike Clarke & Paula R Williamson, 2014. "Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review," PLOS ONE, Public Library of Science, vol. 9(6), pages 1-12, June.
    9. Jamie J Kirkham & Doug G Altman & Paula R Williamson, 2010. "Bias Due to Changes in Specified Outcomes during the Systematic Review Process," PLOS ONE, Public Library of Science, vol. 5(3), pages 1-5, March.
    10. Daniele Fanelli, 2010. "Do Pressures to Publish Increase Scientists' Bias? An Empirical Support from US States Data," PLOS ONE, Public Library of Science, vol. 5(4), pages 1-7, April.
    11. Dongying Li & Tess Menotti & Yizhen Ding & Nancy M. Wells, 2021. "Life Course Nature Exposure and Mental Health Outcomes: A Systematic Review and Future Directions," IJERPH, MDPI, vol. 18(10), pages 1-28, May.
    12. Amin Haghnejad & Mahboobeh Farahati, 2024. "An overview of meta-analytic methods for economic research," Papers 2412.10608, arXiv.org, revised Mar 2025.
    13. Thomas Pfeiffer & Lars Bertram & John P A Ioannidis, 2011. "Quantifying Selective Reporting and the Proteus Phenomenon for Multiple Datasets with Similar Bias," PLOS ONE, Public Library of Science, vol. 6(3), pages 1-7, March.
    14. Ana Virgolino & Osvaldo Santos & Joana Costa & Mónica Fialho & Ivo Iavicoli & Tiina Santonen & Hanna Tolonen & Evangelia Samoli & Klea Katsouyanni & Georgios Baltatzis & Flavia Ruggieri & Annalisa Abb, 2021. "Challenges to Evidence Synthesis and Identification of Data Gaps in Human Biomonitoring," IJERPH, MDPI, vol. 18(6), pages 1-11, March.
    15. Michal Kicinski, 2013. "Publication Bias in Recent Meta-Analyses," PLOS ONE, Public Library of Science, vol. 8(11), pages 1-1, November.
    16. Carl Berning & Bernd Weiß, 2016. "Publication bias in the German social sciences: an application of the caliper test to three top-tier German social science journals," Quality & Quantity: International Journal of Methodology, Springer, vol. 50(2), pages 901-917, March.
    17. Erick H Turner & Andrea Cipriani & Toshi A Furukawa & Georgia Salanti & Ymkje Anna de Vries, 2022. "Selective publication of antidepressant trials and its influence on apparent efficacy: Updated comparisons and meta-analyses of newer versus older trials," PLOS Medicine, Public Library of Science, vol. 19(1), pages 1-21, January.
    18. Thomas J. Kniesner & W. Kip Viscusi, 2023. "Compensating Differentials for Occupational Health and Safety Risks: Implications of Recent Evidence," Research in Labor Economics, in: 50th Celebratory Volume, volume 50, pages 83-116, Emerald Group Publishing Limited.
    19. Carina Benstoem & Ajay Moza & Rüdiger Autschbach & Christian Stoppe & Andreas Goetzenich, 2015. "Evaluating Outcomes Used in Cardiothoracic Surgery Interventional Research: A Systematic Review of Reviews to Develop a Core Outcome Set," PLOS ONE, Public Library of Science, vol. 10(4), pages 1-14, April.
    20. Mangirdas Morkunas & Elzė Rudienė & Lukas Giriūnas & Laura Daučiūnienė, 2020. "Assessment of Factors Causing Bias in Marketing- Related Publications," Publications, MDPI, vol. 8(4), pages 1-16, October.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:plo:pmed00:1000144. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: plosmedicine (email available below). General contact details of provider: https://journals.plos.org/plosmedicine/ .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.