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bioRxiv2018

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

BackgroundSponsors of clinical trials have ethical obligations to register protocols, to report study results and to comply with applicable legal requirements.\n\nObjectiveTo 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).\n\nStudy selectionWebsites 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.\n\nFindingsAmong 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]).\n\nConclusionsMost 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.

scientific communication and education↗

bioRxiv2018

Open access policies of high impact medical journals: a cross-sectional study

ObjectivesAcademic and not-for-profit research funders are increasingly requiring that the research they fund must be published open access, with some insisting on publishing with a Creative Commons Attribution (CC BY) licence to allow the broadest possible use. We set out to clarify the open access variants provided by leading medical journals for research in general and industry-funded research in particular, and record the availability of the CC BY licence for commercially funded research.\n\nMethodsWe identified medical journals with a 2015 impact factor of at least 15.0 on 24 May 2017, then excluded from the analysis journals that only publish review articles. Between 29 June 2017 and 26 July 2017, we collected information about each journals open access policies from their websites and/or by email contact. We contacted the journals by email again between 6 December 2017 and 2 January 2018 to confirm our findings.\n\nResultsThirty-five medical journals publishing original research from 13 publishers were included in the analysis. All 35 journals offered some form of open access with varying embargo periods of up to 12 months. Of these journals, 21 (60%) provided immediate open access with a CC BY licence under certain circumstances (e.g. to specific research funders). Of these 21, 20 only offered a CC BY licence to authors funded by non-commercial organizations and one offered this option to funders who required it.\n\nConclusionsMost leading medical journals do not offer to authors reporting commercially funded research an open access licence that allows unrestricted sharing and adaptation of the published material. The journals policies are therefore not aligned with open access declarations and guidelines. Commercial research funders lag behind academic funders in the development of mandatory open access policies, and it is time for them to work with publishers to advance the dissemination of the research they fund.\n\nStrengths and limitations of this studyO_LIThis manuscript includes a systematic analysis of open access policies of journals with a high impact factor, including society-owned journals, from multiple publishers.\nC_LIO_LIThe open access policies of all journals analysed were clarified, and confirmation of our findings was received by email from 97% of the contacted journals.\nC_LIO_LIOpen access policies of the journals and publishers analysed are subject to change, so the information presented here may not be current.\nC_LIO_LIBy selecting journals with a high impact factor, our analysis does not include prestigious journals from specialized therapy areas and regional or non-English language journals, which may have lower impact factors.\nC_LIO_LIAlthough our study covers only a small number of journals, extending such a manual analysis to a greater number of journals without loss of detail and verification of all results would be cumbersome and inefficient by relying on traditional analysis tools.\nC_LI

scientific communication and education↗