Research & Development World

2016 could be the Year Medical Research Converges on Data Sharing as a Universal Standard

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Opposing the sharing of data may soon find as little overt support within the research community as opposing the theory of gravity.According to a series of articles published this month in PLOS Medicine, data sharing in medical research could soon become the norm. The papers represent authors from the World Health Organization, the pharmaceutical corporation GlaxoSmithKline, the US National Library of Medicine and the International Committee of Medical Journal Editors.

In an accompanying editorial by the PLOS Medicine editors, recent progress toward acceptance of data sharing, in particular for research related to public health emergencies and for reports from clinical trials, is summarized. The editors also outline remaining challenges, including “the need to ensure that researchers who share data receive appropriate recognition.”

They note that “even in morally straightforward cases, data sharing can encounter roadblocks.” This is discussed in a recent Policy Forum by Vasee Moorthy and colleagues at the World Health Organization.1 WHO convened a consultation in September, inviting scientists, medical journal editors, representatives of industry, funding organizations and government. “Specifically, the consultation sought to prevent the kind of delays in data sharing that may have impeded resolution of the 2014-2015 Ebola crisis. Editors attending the consultation — representing BMJ, Nature journals, New England Journal of Medicine and the PLOS journals — were called on to address a concern that data sharing in an emergency could lead to subsequent rejection of research by journals, on the grounds of prior publication.”

After considering issues of particular relevance to clinical trials, including topics presented in the Institute of Medicine report of January 2015,5 editors of the 14 International Committee of Medical Journal Editors (ICMJE) member journals have jointly published a proposed plan. If adopted following public comment, the plan will require data sharing for all clinical trials that will be published in the many journals that endorse ICMJE recommendations.6 “The plan would provide a major impetus for sharing data, reminiscent of the 2004 ICMJE requirement for registration of clinical trials.7 Implementation would mean that researchers wishing to publish clinical trials in any of the large number of participating journals, including some of the most influential venues for clinical trial reports, would need to work with their institutional ethics committees to ensure that, going forward, informed consent language permits sharing of deidentified individual participant data (IPD).”

Beyond the efforts of journal editors, the editorial points out that medical research funders and industry sponsors also have instituted advances in data sharing. “For example, The Bill & Melinda Gates Foundation launched an open access policy in January 2015 including a requirement that data underlying their grantees’ published research be made accessible and open.8 During a 2-year transition period, this policy has permitted a 12-month embargo, but as of January 2017 immediate sharing will take effect.”

Also highlighted is a “progressive data sharing policy” that GlaxoSmithKline (GSK) has implemented for its clinical trials. The policy has been joined by several other companies that now provide access to study data.9

The editors go on to outline substantial challenges to data sharing that still remain to be addressed. These include

  • ensuring the quality of urgently disseminated data and efficiently sharing data across disparate platforms1
  • implications of data sharing for products undergoing regulatory review processes10
  • burdens and costs associated with preparing individual participant data (IPD) and associated documentation for sharing
  • potential for invalid analyses11
  • maintaining confidentiality of study participants

They go on to state that “not the least among challenges will be ensuring due credit for analyses of shared data, so that groups with greater speed or resources for conducting analyses do not gain unduly in reputation at the expense of researchers who share data that they have dedicated their own resources to obtain. While this theme recurs throughout these recent articles, none proposes a specific answer, perhaps because any viable solution necessarily requires action by the clinical research community as a whole.”

They conclude on a positive note that “large and complex organizations and the structures that support them have started changing in order to reduce barriers to data sharing in medical research. The pieces are falling into place with such rapidity that opposing the sharing of data may soon find as little overt support within the research community as opposing the theory of gravity.”

References

  1. Modjarrad K, Moorthy VS, Millett P, Gsell P-S, Roth C, Kieny M-P. Developing Global Norms for Sharing Data and Results during Public Health Emergencies. PLoS Med 2016; 13(1): e1001935. doi: 10.1371/journal.pmed.1001935. pmid:26731342
  2. World Health Organization. Developing global norms for sharing data and results during public health emergencies. http://www.who.int/medicines/ebola-treatment/blueprint_phe_data-share-results/en/? Accessed December 9, 2015.
  3. Whitty CJM, Mundel T, Farrar J, Heymann DL, Davies SC, Walport MJ. Providing incentives to share data early in health emergencies: the role of journal editors. Lancet 2015; 386(10006): 1797–1798. doi: 10.1016/s0140-6736(15)00758-8
  4. International Committee of Medical Journal Editors. Recommendations for the for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals. http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/overlapping-publications.html? Accessed January 5, 2016
  5. Institute of Medicine (IOM). 2015. Sharing clinical trial data:Maximizing benefits, minimizing risk. Washington, DC: The National Academies Press. http://www.nap.edu/catalog/18998/sharing-clinical-trial-data-maximizing-benefits-minimizing-risk? Accessed December 10, 2015.
  6. Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors. PLoS Med. 2016; 13(1): e1001950. doi: 10.1371/journal.pmed.1001950.
  7. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors. 2004 http://www.icmje.org/news-and-editorials/clin_trial_sep2004.pdf Accessed December 9, 2015.
  8. Bill & Melinda Gates Foundation Open Access Policy. http://www.gatesfoundation.org/How-We-Work/General-Information/Open-Access-Policy? Accessed December 10, 2015.
  9. Strom BL, Buyse M, Hughes J, Knoppers BM. Data Sharing, Year 1—Access to Data from Industry-Sponsored Clinical Trials. NEJM 2014; 371: 2052–2054. doi: 10.1056/NEJMp1411794. pmid:25317745
  10. Vallance P, Freeman A, Stewart M. Data Sharing as Part of the Normal Scientific Process: A View from the Pharmaceutical Industry. PLoS Med 2016; 13(1): e1001936. doi: 10.1371/journal.pmed.1001936. pmid:26731493
  11. Zarin DA, Tse T. Sharing Individual Participant Data (IPD) within the Context of the Trial Reporting System (TRS). PLoS Med 2016; 13(1): e1001946. doi: 10.1371/journal.pmed.1001946.
  12. The PLOS Medicine Editors (2016) Can Data Sharing Become the Path of Least Resistance? PLoS Med 13(1): e1001949. doi:10.1371/journal.pmed.1001949 http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001949

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