RT Journal Article
SR Electronic
T1 Commitments by the biopharmaceutical industry to clinical trials transparency: the evolving environment
JF bioRxiv
FD Cold Spring Harbor Laboratory
SP 349902
DO 10.1101/349902
A1 Slavka Baronikova
A1 Jim Purvis
A1 Eric Southam
A1 Julie Beeso
A1 Christopher C Winchester
A1 Antonia Panayi
YR 2018
UL http://biorxiv.org/content/early/2018/06/18/349902.abstract
AB Introduction All sponsors of clinical research have ethical obligations to register protocols and report the results of their studies in a timely and transparent manner; and for applicable trials, they must also comply with the legal requirements imposed by regulators.Objective To evaluate the extent to which biopharmaceutical companies that are members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and/or the Pharmaceutical Research and Manufacturers of America (PhRMA) have made public their commitments to clinical trials disclosure, in comparison with non-members, and to assess the extent to which they are disclosing clinical trial data, in comparison with non-members and non-industry funders.Methods Websites of the top 50 biopharmaceutical companies (“top 50 companies”) as ranked by 2015 global sales were searched for statements relating to clinical trial data disclosure. The disclosure of data to April 2017 by biopharmaceutical industry and non-industry sponsors with at least 30 interventional phase II-IV clinical trials registered on ClinicalTrials.gov and completed during 2006-2015 was assessed using the independent online tool TrialsTracker. Biopharmaceutical industry sponsors were stratified by sales and EFPIA/PhRMA membership.Results Among the top 50 companies, 30 were EFPIA/PhRMA members and were pharmaceutical/biotechnology companies; the 20 non-members were biopharmaceutical/biotechnology, generics/biosimilars, medical devices, intravenous products, plasma products, and nutraceuticals companies. A general statement committing to disclosure of clinical trial data was found on 26 of the top 50 company websites (52%): all 26 were EFPIA/PhRMA members. Disclosure statements were easily accessible (within four clicks) for 19 EFPIA/PhRMA members. A statement referring to the adoption of EFPIA/PhRMA disclosure principles was found on 20/30 (67%) member websites. Of 29 377 trials listed in TrialsTracker, 9511 were sponsored by 69 biopharmaceutical industry companies (mean 138 trials per company) and 19 866 were sponsored by 254 non-industry institutions (mean 78 trials per institution). The mean disclosure rate for these trials was 55%, with rates higher for industry (74%) than for non-industry sponsors (46%). For the 30 companies in TrialsTracker that were among the top 50 companies, the mean disclosure rate was 76%. Within this group of 30 companies, 25 were EFPIA/PhRMA members, the mean disclosure rate for 25 EFPIA/PhRMA members and 5 non-members was 77% and 67%, respectively.Conclusions Our research shows that the majority of the top 50 biopharmaceutical companies have made public commitments to the disclosure of clinical trial data. For most EFPIA/PhRMA members, such commitments are easily accessible. Biopharmaceutical industry sponsors have responded to the ethical and legal demands of clinical trial disclosure to a greater extent than non-industry sponsors.