Who is publishing their clinical trial results? Do biopharmaceutical industry sponsors carry an unfair burden of the blame for the under-reporting of clinical trial results?
Following suggestions of under-reporting of clinical trial results,1 recently published research has shed light on how many biopharmaceutical companies have publicly stated their commitments to the disclosure of results and on the disclosure rates of both biopharmaceutical industry and non-industry clinical trial sponsors.2 This research was a result of a collaboration between Oxford PharmaGenesis, a leading, independently owned HealthScience communications consultancy, and Shire (now part of Takeda), a global speciality biopharmaceutical company.
Our research evaluated the public commitments to disclosure of clinical trial results and the rates of disclosure made by the top 50 biopharmaceutical companies by 2015 sales, stratified by membership of two large pharmaceutical trade associations: the European Federation of Pharmaceutical Industries and Associations (EFPIA) and/or the Pharmaceutical Research and Manufacturers of America (PhRMA).
We first searched the websites of the top 50 biopharmaceutical companies for statements relating to commitment to clinical trial data disclosure. Next, we estimated the performance of all the sponsors of 30 clinical trials or more between 2006 and 2015 using the online TrialsTracker tool (https://trialstracker.ebmdatalab.net/#/); results were stratified by being one of the top 50 companies and by membership of EFPIA and/or PhRMA.
We found that 30 of the top 50 companies were EFPIA/PhRMA members and 20 were non‑members, and found statements committing to the disclosure of clinical trial results on the public websites of 26 of the EFPIA/PhRMA members but not on the websites of any of the non-members (Figure 1).
Across all trials, the mean disclosure rate was 55%, with higher disclosure rates for industry (74%) than for non-industry sponsors (46%). Of the 30 companies within the top 50 with data available in TrialsTracker, the mean disclosure rate was 76% (77% for EFPIA/PhRMA members [n = 25] versus 67% for non-members [n = 5]) (Figure 2).
Our research has shown that most of the top 50 biopharmaceutical companies have publicly committed to the disclosure of clinical trial results, and that industry sponsors have responded to the ethical and legal demands of trial disclosure by disclosing the results of three-quarters of their trials. This compares with a disclosure rate of less than half for non-industry sponsors. Despite these encouraging results for the biopharmaceutical industry, further improvements in clinical trial results disclosure are needed across all sponsors.
This research has been published in BMJ Evidence-Based Medicine and is freely available here: https://ebm.bmj.com/content/early/2019/03/21/bmjebm-2018-111145.
Data from https://trialstracker.ebmdatalab.net/#/.
References
- Powell-Smith A, Goldacre B. The TrialsTracker: automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions. F1000Res 2016;5:2629.doi:10.12688/f1000research.10010.1.
- Baronikova S, Purvis J, Southam E, Beeso J, Panayi A, Winchester C. Commitments by the biopharmaceutical industry to clinical trial transparency: the evolving environment. BMJ evidence-based medicine 2019.doi:10.1136/bmjebm-2018-111145.
