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Commitments by the biopharmaceutical industry to clinical trials transparency: the evolving environment

Slavka Baronikova, Jim Purvis, Eric Southam, Julie Beeso, Christopher Winchester, Antonia Panayi
doi: https://doi.org/10.1101/349902
Slavka Baronikova
Shire International GmbH;
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Jim Purvis
Oxford PharmaGenesis
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  • For correspondence: jim.purvis@pharmagenesis.com
Eric Southam
Oxford PharmaGenesis
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Julie Beeso
Oxford PharmaGenesis
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Christopher Winchester
Oxford PharmaGenesis
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Antonia Panayi
Shire International GmbH;
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Abstract

Background: Sponsors of clinical trials have ethical obligations to register protocols, to report study results and to comply with applicable legal requirements. Objective: To evaluate public commitments to trial disclosure and rates of disclosure by members and nonminusmembers of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and/or the Pharmaceutical Research and Manufacturers of America (PhRMA). Study selection: 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 (2006minus2015) was assessed using TrialsTracker. Findings: 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] versus 67% for non-members [n = 5]). Conclusions: 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 to a greater extent than non-industry sponsors, and now disclose three quarters of their trials.

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The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC 4.0 International license.
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Posted November 12, 2018.
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Commitments by the biopharmaceutical industry to clinical trials transparency: the evolving environment
Slavka Baronikova, Jim Purvis, Eric Southam, Julie Beeso, Christopher Winchester, Antonia Panayi
bioRxiv 349902; doi: https://doi.org/10.1101/349902
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Commitments by the biopharmaceutical industry to clinical trials transparency: the evolving environment
Slavka Baronikova, Jim Purvis, Eric Southam, Julie Beeso, Christopher Winchester, Antonia Panayi
bioRxiv 349902; doi: https://doi.org/10.1101/349902

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