Search

In response to the growing consensus among funders, research foundations and government agencies to require the sharing of clinical trial data, the International Committee of Medical Journal Editors (ICMJE) has issued, and invited comments on, a proposal outlining it's requirements to support this obligation. In essence, for a clinical trial report to be considered for publication in an ICMJE member journal, authors will be required to share individual patient data within 6 months of publication. While on the surface this appears to be a clear-cut and fairly straightforward requirement, consideration of the implications reveals a plethora of issues, some of them potentially far reaching. In this article I explore some of the advantages and potential disadvantages of such a policy. As laid out in the EASE Statement on Data Sharing, issued on 4 April 2016 "EASE is in agreement with the recently proposed requirement from the International Committee of Medical Journal Editors (ICMJE) that makes sharing of clinical trial data mandatory for manuscript acceptance by its member journals". The benefits of data sharing and transparency are many. Analyses can be repeated, either to be verified, or in some cases, to be shown to be erroneous before they become completely embedded in the scientific record or have an effect on clinical practice; data can be re-used in addressing new but related research questions, thus reducing research waste3 and falsification should become ever more difficult to get away with. All in all, data sharing can positively influence many things - retaining and possibly elevating the public's trust in science, the advancement of medical care, and the generation of new insights into clinical practice. Importantly, the benefits that the few grant to the many - results derived from clinical trials made possible by the patients who take part in them (often in the knowledge that they may be putting themselves at risk) are acknowledged. As an absolute minimum we, as a society, should ensure that full and judicious use is made of data obtained, and any potential benefit to the health of the populace is exploited. Data transparency is not, per se, an entirely new thing. The European Medicines Agency made data sharing a legal requirement in October 2014 when it published its final policy on publication of clinical data, and this year we will see publication of the first compliant reports thus completing the journey from trial inception to completion with final results, down to the patient level, being completely transparent. So, like many new initiatives, data sharing is a good one, and is to be applauded. But like all good ideas, the more one investigates it, the more complex it becomes. Even though I'm all in favour of transparency, for all the reasons given above, I can't help but think the concept may become so complex with all its various ramifications, as to be virtually non-implementable. As I became more involved with the EASE Statement on Data Sharing, many questions presented themselves, and like others I came to realise that this isn't a simple matter of putting data in a database somewhere for all to access at will - there are many, many more issues to be considered, and potentially dozens of procedures to put in place. In fact, the whole process starts to 'grow like Topsy'. [ABSTRACT FROM AUTHOR]

The article presents author' comments on managing the expectations of authors with the obstacles in peer review. It focuses on reformatting the manuscripts for alternative journals. It mentions that the reformatted manuscripts were submitted to the alternate journals and same reviewers suggested during the submission process.