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.

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word count: 246/250 ABSTRACT BackgroundSponsors of clinical trials have ethical obligations to register protocols, to report study results and to comply with applicable legal requirements. ObjectiveTo 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). Study 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)(2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015) was assessed using TrialsTracker. FindingsAmong 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]). ConclusionsMost 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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ObjectivesTo evaluate disclosure of clinical trials registered by pharmaceutical companies using an independent, semi-automated tool (TrialsTracker; https://trialstracker.ebmdatalab.net/#/).MethodFor the top 50 pharmaceutical companies (2014 global sales; EvaluatePharma, London, UK), registered interventional phase 2–4 clinical trials completed in 2006–2015 were identified in TrialsTracker, which calculates annual disclosure rates for sponsors of over 30 studies registered on ClinicalTrials.gov. The proportion of trials with results disclosed by April 2017 was analysed by company membership of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA).ResultsIn total, 323 clinical trial sponsors were listed in TrialsTracker, of which 69 were pharmaceutical industry sponsors and 31 were ranked in the top 50 pharmaceutical companies. Of these, 25/31 were EFPIA/PhRMA members and 6/31 were non-members. The disclosure rate for each year from 2006 to 2015 was 42.9%, 54.4%, 81.0%, 86.1%, 84.6%, 87.2%, 89.3%, 82.1%, 84.1% and 73.4%; reporting of clinical trial results became mandatory in 2008. The disclosure rate (disclosed trials/eligible trials) between 2006 and 2015 was greater for all pharmaceutical industry sponsors (7037/9511 [74.0%]) than for non-industry sponsors (9074/19866 [45.7%]) (p<0.01). For the top 50 companies, results were disclosed for 4761/6235 trials (76.4%) between 2006 and 2015, with similar disclosure rates for EFPIA/PhRMA members (4336/5697 [76.1%]) and non-members (425/538 [79.0%]).ConclusionsAccording to TrialsTracker, the pharmaceutical industry has disclosed the results of three quarters of trials completed between 2006 and 2015. The disclosure rate for pharmaceutical industry sponsors is greater than for non-industry sponsors. Because TrialsTracker excludes sources other than ClinicalTrials.gov (e.g. company websites), this figure may be an underestimate.