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Commitments by the biopharmaceutical industry to clinical trial transparency: the evolving environment
  1. Slavka Baronikova1,
  2. Jim Purvis2,
  3. Eric Southam2,
  4. Julie Beeso2,
  5. Antonia Panayi1,
  6. Christopher Winchester2
  1. 1 Shire International GmbH (now part of Takeda), Zug, Switzerland
  2. 2 Oxford PharmaGenesis Ltd, Tubney, UK
  1. Correspondence to Dr Slavka Baronikova, Shire International GmbH (now part of Takeda), Zug, Switzerland; slavka.baronikova{at}takeda.com

Abstract

Clinical trial sponsors have ethical obligations to register protocols, report study results and comply with applicable legal requirements. To evaluate public commitments to trial disclosure and rates of disclosure by members and non-members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and/or the Pharmaceutical Research and Manufacturers of America (PhRMA). Websites of the top 50 biopharmaceutical companies by 2015 sales were searched for statements relating to trial data disclosure. Disclosure of trial results completed by biopharmaceutical industry and non-industry sponsors of at least 30 trials (2006–2015) was assessed using TrialsTracker. Among the top 50 companies, 30 were EFPIA/PhRMA members and 20 were non-members, of which 26 and none, respectively, had a statement on their website committing to the disclosure of trials data. Of 29 377 trials in TrialsTracker, 9511 were industry sponsored (69 companies) and 19 866 were non-industry sponsored (254 institutions). The overall mean disclosure rate was 55%, with higher rates for industry (74%) than for non-industry sponsors (46%). Of the 30 companies within the top 50 with data in TrialsTracker, the mean disclosure rate was 76% (77% for EFPIA/PhRMA members [n=25] vs 67% for non-members [n=5]). Most of the top 50 biopharmaceutical companies have publicly committed to the disclosure of trial data. Industry sponsors have responded to the ethical and legal demands of trial disclosure by disclosing three quarters of their trials compared with less than half for non-industry sponsors. Further improvements in clinical trial disclosure are needed.

  • Clinical trials
  • transparency
  • disclosure
  • reporting

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Footnotes

  • Contributors All authors contributed to the planning, conduct and reporting of the work described in this article. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding Funding was provided by Oxford PharmaGenesis and Shire (now part of Takeda), employees of which reviewed and approved the draft text.

  • Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: JP, ES, JB and CW are employees of Oxford PharmaGenesis, Oxford, UK, which receives funding from multiple pharmaceutical companies for the provision of medical communications support. CW owns shares in Oxford PharmaGenesis Holdings Ltd; AP and SB are employees Shire International GmbH (now part of Takeda).

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

  • Data sharing statement The data presented in this article are updated from the following presentations: SB, JP, JB, ES, CW, AP. Commitments to data sharing by pharmaceutical companies: the evolving environment. Presented at the 2017 European Meeting of the International Society for Medical Publication Professionals (ISMPP), London, UK, 17–18 January 2017 [poster presentation]. SB, JP, JB, ES, CW, AP. Commitments to data sharing by pharmaceutical companies: the evolving environment. Presented at the 2017 Annual Meeting of ISMPP, National Harbor, Maryland, USA, 1–3 May 2017. Curr Med Res Opin 2017;33(Suppl 1):7 [oral presentation]. SB, JP, JB, ES, CW, AP. Disclosure of results of clinical trials sponsored by pharmaceutical companies. Presented at the 2017 Meeting of the International Peer Review Congress (PRC), Chicago, IL, USA, 10–12 September 2017 [poster presentation]. SB, JP, CW, ES, JB, AP. Disclosure of results of clinical trials sponsored by pharmaceutical companies. Presented at the 2018 European Meeting of ISMPP, London, UK, 23–24 January 2018 [poster presentation]. This research was also presented at Evidence Live 2018, Oxford, UK, 18–19 June 2018.This article is available as a preprint at https://www.biorxiv.org: SB, JP, ES, JB, CW, AP. Commitments by the biopharmaceutical industry to clinical trials transparency: the evolving environment. 2017;bioRxiv 349902; doi: https://doi.org/10.1101/349902.

  • Patient consent for publication Not required.

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