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Why an automated tracker finds poor sharing of clinical trial results for an academic sponsor: a bibliometric analysis

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Abstract

Objective: a Researchers have a duty to make the results of their research available publicly. According to the FDA, clinical trial data must be made public less than 12 months after the end of the trial. The trialstracker website (https://trialstracker.ebmdatalab.net/#/) ranks sponsors according to the proportion of unpublished clinical trials by extracting data from a prospective trial registry: clinicaltrials.gov. A low proportion of published trials could be explained by a failure to share results or the sponsor incorrectly filling out the clinicaltrials.gov database. The objective of this study was to assess for which of these reasons one academic sponsor was shown to have a high proportion of unpublished results. Methods: Bibliographic searches were performed and followed up with an email contact for the 104 HCL (Hospices Civils de Lyon, France) trials used by trialstracker to assess publication status. Results: Trialstracker considered that only 25 out of the 104 HCL trials had been published. By searching PubMed between February and April 2019, we rapidly identified publications for 27 further trials. A more advanced search and contact with the investigators allowed us to identify 24 more published trials. Overall, the proportion of trials published was 72.1% (n = 75) i.e. 3 times higher than the proportion provided by trialstracker. Even when restricted to the results found via a simple search, the proportion of publications was still higher with a two-fold increase. Conclusion: We found that trialstracker greatly underestimated the number of publications. All actors should therefore contribute to improving the visibility of clinical trial results by providing NCT numbers for all publications (investigator), and by updating clinicaltrials.gov (sponsor and investigator).

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Data availability

Data used in the study is available on clinicaltrials.gov and trialstracker, our study dataset is available upon request.

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Acknowledgements

We would like to thank the HCL research division for their help in retrieving trial information and updating clinicaltrials.gov. We also thank Florence Bouriot for her help in providing articles.

Special thanks to all the investigators for their rapid replies to our emails. We also thank Mrs Barrett (Version Originale) for English editing.

Funding

This project was not funded.

Author information

Authors and Affiliations

  1. Hospices Civils de Lyon, Pôle Santé Publique, Service Recherche et Epidémiologie Cliniques, 162 Avenue Lacassagne, 69003, Lyon, France

    E. Decullier, P. V. Tang & L. Huot

  2. Université de Lyon, 69002, Lyon, France

    E. Decullier & L. Huot

  3. Université Lyon 1, 69008, Lyon, France

    E. Decullier & L. Huot

  4. Medical Writing, Paris, France

    H. Maisonneuve

Authors
  1. E. Decullier
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  2. P. V. Tang
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  3. L. Huot
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  4. H. Maisonneuve
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Contributions

DE: conceived the study, classified studies and drafted the manuscript; TPV: collected and analyzed the data; HL: conceived the study, classified studies and revised the manuscript; MH: conceived the study, and drafted the manuscript.

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Correspondence to E. Decullier.

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No humans were involved. No ethical authorization was required.

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Decullier, E., Tang, P.V., Huot, L. et al. Why an automated tracker finds poor sharing of clinical trial results for an academic sponsor: a bibliometric analysis. Scientometrics 126, 1239–1248 (2021). https://doi.org/10.1007/s11192-020-03775-0

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  • DOI: https://doi.org/10.1007/s11192-020-03775-0

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