(Data) Sharing is Caring … Or is It?

Last year’s proposal by the ICMJE (International Committee of Medical Journal Editors) on sharing of individual patient data for clinical trials generated much debate and controversy. Now, the ICMJE has released their initial minimum data sharing requirements for future trial publications… But what do they mean for the research community, communications agencies, and, ultimately, for patients?

The new guidance requires all manuscripts submitted to ICMJE member journals, effective from 1 July 2018, to include a ‘data sharing statement’ specifying if, and how, individualised and anonymised patient data will be shared (Figure 1). Trials enrolling after 1 January 2019 will also require a ‘data sharing plan’ in their registration, to be updated with any subsequent changes. These requirements are in sharp contrast to the more stringent proposals put to the community in 2016, which envisioned mandatory individualised data sharing within 6 months of publication.

Last year’s proposals sparked intense debate online and in the editorial pages of medical journals, with much concern over the risk to patient privacy, the potential for incorrect secondary data analysis, and appropriate scholarly credit for the originators of the data, among other objections. Many other voices welcomed the idea of mandatory data sharing. Indeed, the potential of data sharing to facilitate more rigorous meta-analyses, uncover new and unexpected research avenues and identify biases in published research led to calls for the proposal to go even further.

Yet the new requirements show that the ICMJE has taken note of the critics’ concerns while, in their words, “[moving] the research enterprise closer to fulfilling our ethical obligations to patients”. The announcement makes clear that they will continue to seek solutions from the research community on unresolved issues and the practicalities of implementing mandatory data sharing in the future.

So where do we, as medical communications professionals, come in? We work at a key juncture in the dissemination of clinical data to doctors and the public, and need to be ready to advise clients on how these guidelines will affect them. Individual journals may, and some already do, take a more transparent view on this issue. Agencies will therefore have an important role in liaising between journals and authors, helping clients plan when and how much data to share, and understanding the implications of these decisions on where trials can be published.

Patients risk their lives and their health to take part in clinical trials, and this gives all of us working in healthcare a moral imperative to derive the maximum benefit from their sacrifice, for the improved care of all patients. This, ultimately, is AXON’s mission.