Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study
BMJ 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)
Dear Editor:
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 [3], 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) [7], 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.
Sincerely,
Al Weigel
President and CEO, International Society for Medical Publication Professionals (ISMPP)
References
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 [1], 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
[1] Mayo-Wilson E, Doshi P, Dickersin K (2015). Are manufacturers sharing data as promised? BMJ 351:h4169. PMID: 26407814
Competing interests: No competing interests
Observing a Lack of Data Sharing in Observational Studies
We read with interest the recent article by Goldacre and colleagues auditing clinical trial data sharing 1. One point we have noticed, however, is that whilst there are a number of articles calling for the sharing of clinical trial data 1 2, the access to and sharing of real-world/observational data receives little and arguably insufficient attention. This is despite the important uses of these data, as exemplified by the recent ‘weekend effect’ issue in the UK 3 4, as well as their application to National clinical guidelines 5.
The BMJ does not enforce a commitment to data sharing for observational studies 6, but all research articles are required to contain a data sharing statement 7. A review of the data sharing statements of 237 observational studies published in the BMJ between January 2015 and August 2017 revealed that 63% of studies had a statement implying that the data underlying the study could not be shared 8. Whilst there are likely many reasons for this, including patient confidentiality concerns, the result is generally reflective of the current state of observational research where many data sources across the world are not readily accessible, and nor is the data shared after a study is completed 9 10.
As noted by Davey-Smith in the BMJ over 20 years ago 11, shared data can be used to answer new questions about disease as well as validating the initial analyses. The former has been evidenced recently with trial data sharing 12 13 14. Policy and privacy issues to increase real-world data access and sharing need to be addressed as this is a potential barrier to scientific advancement. Improved, responsible data access and sharing could in turn allow for more effective use of limited healthcare resources and offers significant potential for improvements in healthcare.
References
1. Goldacre, B. et al. Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study. BMJ 358, j3334 (2017).
2. Krumholz, H. M. & Peterson, E. D. Open Access to Clinical Trials Data. JAMA 312, 1002–1003 (2014).
3. Replies to A national health care data network is overdue. Available at: http://www.cmaj.ca/content/189/29/E951/reply#cmaj_el_733383. (Accessed: 2nd September 2017)
4. McKee, M. The weekend effect: now you see it, now you don’t. BMJ 353, i2750 (2016).
5. Oyinlola, J. O., Campbell, J. & Kousoulis, A. A. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances. BMC Health Serv. Res. 16, 299 (2016).
6. Research | The BMJ. Available at: http://www.bmj.com/about-bmj/resources-authors/article-types/research. (Accessed: 2nd September 2017)
7. Groves, T. Managing UK research data for future use. BMJ 338, b1252 (2009).
8. McDonald, L. et al. A review of data sharing statements in observational studies published in the BMJ: A cross-sectional study. F1000Research 6, 1708 (2017).
9. García Álvarez, L. et al. Data linkage between existing healthcare databases to support hospital epidemiology. J. Hosp. Infect. 79, 231–235 (2011).
10. Moulis, G. et al. French health insurance databases: What interest for medical research? Rev. Médecine Interne 36, 411–417 (2015).
11. Smith, G. D. Increasing the accessibility of data. BMJ 308, 1519–1520 (1994).
12. Burns, N. S. & Miller, P. W. Learning What We Didn’t Know — The SPRINT Data Analysis Challenge. N. Engl. J. Med. 376, 2205–2207 (2017).
13. Guinney, J. et al. Prediction of overall survival for patients with metastatic castration-resistant prostate cancer: development of a prognostic model through a crowdsourced challenge with open clinical trial data. Lancet Oncol. 18, 132–142 (2017).
14. Wilkerson, J. et al. Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer: a retrospective analysis. Lancet Oncol. 18, 143–154 (2017).
Competing interests: SR and LM are employees of Bristol-Myers Squibb. AS, AS, SG and RW are employees of Evidera.