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Clinical Trials: Recommendations on How, When and What to Share

Clinical trials play a vital role in the development of new medical advances: They are used to determine the effects of health-related interventions on specific health outcomes, and we would not have new drugs, medical devices or behavioral interventions without them. Therefore, sharing clinical trial data could benefit society by extending scientific discoveries beyond those from any single study. Unfortunately, data generated by clinical trials are often neither public nor shared beyond the data holder—and the best way to go about sharing this information is not always simple or straight forward.

With that in mind, the Doris Duke Charitable Foundation joined 22 other organizations in supporting a committee convened by the Institute of Medicine (IOM) to develop guiding principles for the responsible sharing of clinical trial data. The result of that work is a report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, which provides recommendations on how, when and what data to share from trials that test medical innovations.

Among other things, it addresses the many issues that must be worked out before data is shared. For example, a survey of clinical researchers supported by the Doris Duke Charitable Foundation pointed out the following issues and concerns:

  • Threats to the privacy of subjects
  • Lack of quality control of secondary analyses
  • Cost and time
  • Lack of standards for sharing, including when and where to share

It is clear that the scientific community needs a set of guiding principles for how to share clinical trial data in a fair, responsible and worthwhile manner that serves the public interest. The IOM committee took great care to make recommendations that mitigate the risks while enhancing the benefits of sharing potentially sensitive information.

The key recommendations are to:

  1. Foster a culture of data sharing. The report recommends approaches to achieve this for various stakeholders.
  2. Share data at specific times before, during and after the clinical trial.  
  3. Use strategies such as independent review panels to determine what information should be shared to serve the public interest.
  4. Assemble stakeholders from academia, industry, funding organizations and patient advocacy groups in an ongoing fashion to continue to address data sharing challenges. 

Please see the full report for details on the recommendations.



April 19, 2016 – An update

This month, DDCF was pleased to learn that the International Committee of Medical Journal Editors (ICMJE), in light of growing, field-wide support for sharing data from clinical trials as outlined above, proposed a set of requirements for ICMJE’s journals to meet that goal. The committee outlined its ideas in an article entitled “Sharing Clinical Trial Data” in The New England Journal of Medicine on Jan. 28, 2016, and subsequently in JAMA on Feb. 2, 2016. If implemented, an author would have to meet these future requirements for his or her clinical trial report to be published in an ICMJE member journal.

The ICMJE’s suggested conditions for a report’s publication include, for example, sharing the de-identified patient data behind the study’s results within six months of publication and identifying a plan for data sharing as a part of clinical trial registration.

Before implementing these conditions, the ICMJE invited the scientific community to offer and post feedback. On April 19, the feedback was made publicly available at DDCF looks forward to learning how this discussion develops and results in a stronger and more mutually supportive scientific community.