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

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.

Creation of an Integrated Clinical Trial Database and Data Sharing for Conducting New Research by the Japan Lung Cancer Society

“… 1 The Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations in 2013 and the International Federation of Pharmaceutical Manufacturers & Associations in 2018 made it a principle to disclose and share trial data, including individual data, to researchers; hence, many trial data are now actually disclosed. 2 For example, Clinical Study Data Requext.com is a clinical trial data-sharing portal site available to multiple companies, and as of February 2022, 13 companies had participated, in which 689 studies were proposed and 533 were approved to date. Nevertheless, only company-accepted studies are eligible, and there is no integration of clinical trial data.…”

Landscaping the terminology of accessible language document types

“…Secondly, the selection of the methods of the sample cohort likely introduced biases and may not be representative of the wider industry; EFPIA member organisations are known to have improved rates of results reporting compared with the industry as a whole. 31 Further, results reporting of unregistered epidemiological and observational studies and medical devices are also not represented by this cohort. Thirdly, the limited global representation of the sample selection did not allow for robust conclusions to be drawn for geographic regions beyond Europe and North America and focused on English language lay summaries.…”

Plain Language Summaries of Clinical Trial Results: A Preliminary Study to Assess Availability of Easy-to-Understand Summaries and Approaches to Improving Public Engagement

“…Consequently, there has been a push to establish policies and practices to facilitate patient and public involvement and participation in clinical research. In the European Union, Clinical Trial Regulation (Regulation [EU] No 536/2014) is a major step towards improving the transparency of clinical research, thereby potentially increasing engagement with patients and the public [ 11 ]. This regulation creates the Clinical Trials Information System (CTIS) for studies conducted within The European Union.…”