The BMJ posted ISMPP’s Rapid Response on August 9, 2017, to an informative article titled, “Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study,” authored by Goldacre and colleagues, and published in The BMJ on July 26, 2017 (BMJ 2017;358:j3334; doi: 10.1136/bmj.j3334). The article reported on the first global industry analysis of the policies of pharmaceutical companies related to transparency of clinical trials, which included the submission of clinical trial manuscripts to journals.
In its Rapid Response, ISMPP thanked Goldacre and colleagues for this industry analysis, and raised various points about the 42 company policies reviewed as part of the audit, including the policies of the top 23 pharmaceutical companies. ISMPP’s Rapid Response is shown in part below.
While variations were noted in the 42 company policies reviewed as part of the audit, it was constructive to find that a majority of the companies had policies that commit to the registration of all trials, availability of summary results, sharing of clinical study reports (CSRs), and availability of individual patient data (IPD) from clinical trials on request. In fact, over 90% of the top 23 pharmaceutical companies in the audit had policies that met all four of these transparency commitments.
With regards to the audit study’s findings related to the commitment to submit all trial results to an academic journal within 12 months of trial completion, the timeframes for manuscript submission in current guidelines [1,2] recommend the following:
- For licensed products, manuscripts should be submitted within 12 months (or 18 months at the latest) of study completion.
- For investigational products, manuscripts should be submitted within 12 months (or 18 months at the latest) of product approval or within 18 months of product discontinuation.
These guidelines, along with the usual timeframes needed for manuscript development, including managing challenges associated with data analysis/verification and coordination of author input , may be reflected in the audit study’s findings on the timing for manuscript submissions in the pharmaceutical companies’ policies. Recent clinical trial transparency regulations from the European Medicines Agency (EMA) and the US National Institutes of Health (NIH) [4-6], plus new data sharing requirements from the International Committee of Medical Journal Editors (ICMJE) , are likely to evolve the guidelines on timeframes for manuscript submission and, in turn, the policies of pharmaceutical companies.
Finally, we agree on the need to also look at transparency actions and policies by academic journals, academic institutions, and non-commercial sponsors as a basis of understanding trial transparency across all entities, not just pharmaceutical companies.
The Rapid Response was authored by Al Weigel, ISMPP’s President and CEO, with input from the ISMPP Board of Trustees. The Society is pleased that The BMJ chose to post ISMPP’s Rapid Response. We invite ISMPP members to read the Rapid Response at the following link: www.bmj.com/content/358/bmj.j3334/rapid-responses.
- Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015;163:461-464; doi:10.7326/M15-0288.
- International Federation of Pharmaceutical Manufacturers & Associations; European Federation of Pharmaceutical Industries and Associations; Japan Pharmaceutical Manufacturers Association; Pharmaceutical Research and Manufacturers of America. Joint position on the publication of clinical trial results in the scientific literature. 10 June 2010. Accessed at www.ifpma.org/resource-centre/new-industry-position-requires-submission-for-journal-publication-of-all-phase-iii-clinical-trials/ on 2 August 2017.
- Mooney LA, Fay L. Cross-sectional study of Pfizer-sponsored clinical trials: assessment of time to publication and publication history. BMJ Open 2016;6: e012362; doi:10.1136/bmjopen-2016-012362.
- EU no 536/2014. https://ec.europa.eu/health/human-use/clinical-trials/regulation_en#ct4. Accessed 7 August 2017.
- EMA Policy 0070. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000556.jsp. Accessed 7 August 2017.
- US NIH Final Rule. https://prsinfo.clinicaltrials.gov/. Accessed 7 August 2017.
- Taichman DB, Sahni P, Pinborg A, et al. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Ann Intern Med 2017; doi:10.7326/M17-1028.