Pharmaceutical companies’ policies on access to trial data, results, and methods: audit studyBMJ 2017; 358 doi: https://doi.org/10.1136/bmj.j3334 (Published 26 July 2017) Cite this as: BMJ 2017;358:j3334
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RE: Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study (BMJ 2017;358:j3334; doi: 10.1136/bmj.j3334)
We read with great interest the article titled “Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study,” by Ben Goldacre, published in The BMJ on 26 July 2017. The International Society for Medical Publication Professionals (ISMPP), a not-for-profit professional society with over 1,500 members involved in the publication of medical research, would like to thank Goldacre and colleagues on the first global industry analysis of the policies of pharmaceutical companies related to transparency of clinical trials.
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.
President and CEO, International Society for Medical Publication Professionals (ISMPP)
1. 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.
2. 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-... on 2 August 2017.
3. 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.
4. EU no 536/2014. https://ec.europa.eu/health/human-use/clinical-trials/regulation_en#ct4. Accessed 7 August 2017.
5. EMA Policy 0070. http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general.... Accessed 7 August 2017.
6. US NIH Final Rule. https://prsinfo.clinicaltrials.gov/. Accessed 7 August 2017.
7. 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.
Competing interests: I have read and understood BMJ policy on declaration of interests and declare the following interests: I previously worked for several pharmaceutical companies on medical publication teams, and currently serve as President and CEO of ISMPP. ISMPP is a not-for-profit professional society that is largely comprised of members from the pharmaceutical and medical communications profession, with funding derived from medical publications-related programs and memberships. Review and input was received by some ISMPP staff and the ISMPP Board of Trustees.
Although we find it promising that many companies have made public statements about sharing clinical trial information, it remains unclear whether companies adhere to their own policies.
As we reported previously , we contacted AstraZeneca to request information that we expected to be available in accordance with their published policy. After a lengthy exchange, AstraZeneca declined our request.
Further research is needed to determine the extent to which companies are practicing the transparency policies to which they are committed in theory.
Evan Mayo-Wilson and Kay Dickersin
Center for Clinical Trials and Evidence Synthesis
Johns Hopkins University Bloomberg School of Public Health
 Mayo-Wilson E, Doshi P, Dickersin K (2015). Are manufacturers sharing data as promised? BMJ 351:h4169. PMID: 26407814
Competing interests: No competing interests