On January 20, members of the International Committee of Medical Journal Editors (ICMJE) announced a proposal that would require the authors of clinical trial publications to share the deidentified individual patient data that support their published results within 6 months of publication. Announced in an editorial published simultaneously in multiple medical journals, this proposal is based on the belief that authors have an “ethical obligation to responsibly share data generated by interventional clinical trials.” It also reflects the broader agenda of the ICMJE to foster greater transparency and reduce the potential for bias. This new requirement will likely go into effect in 2016 and will affect any clinical trial that enrolls patients beginning 1 year after ICMJE adopts the requirement.
This proposal makes a lot of sense in the interest of transparency, but what does it mean for clinical investigators involved in research and the companies that sponsor that research? To quote the ICMJE authors, “enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used.”
The practical reality is that data sharing will place a substantial burden on investigators, study sponsors, and the CROs who collect and analyze the clinical data, because those data will have to be stored in a way that is accessible to the public or uploaded to some type of public database. This may come with a high price tag in terms of the additional time and resources expected to be involved in this process, including the cost of housing the data, which may be especially difficult for small pharma to manage. The details regarding how this would be implemented have yet to be revealed.
In addition, there are concerns about loss of control and ownership of the data. Once the patient-level data are made available, they will be fair game for anyone to analyze any way they choose. Although this may facilitate patient-level meta-analyses and subset analyses that could provide new insights, it could also have negative ramifications. For example, a competitor with an agenda could manipulate the data to undermine confidence in the original interpretation of a trial. Data sharing could also create a host of issues related to authorship and attribution that will need to be resolved to ensure that individual investigators/trial groups are able to publish secondary analyses. Delayed publication of the primary trial data could be a consequence. Thus, data sharing may be a difficult pill to swallow for pharma companies and clinical investigators who are accustomed to having some measure of control over how their data are viewed and interpreted.
From their point of view, ICMJE envisions that data sharing will “increase confidence and trust in the conclusions drawn from clinical trials, enable the independent confirmation of results (an essential tenet of the scientific process), and foster the development and testing of new hypotheses.” It may also accelerate progress in clinical research by reducing unnecessary repetition. The ICMJE authors of the editorial said, “We believe it will benefit patients, investigators, sponsors, and society.”
Public comment is being invited until April 18, 2016. It will be interesting to see how ICMJE will address the issues and concerns of the medical community. In any event, this proposal will usher in a new era in medical publishing.
Jeff Riegel, PhD, combines his scientific expertise in molecular biology with 20 years of global healthcare agency experience guiding medical and regulatory communication strategies for biopharma companies. Jeff helps clients prepare for FDA Advisory Committee meetings and directs publications planning and execution in oncology and other therapeutic areas. Connect with Jeff on LinkedIn.