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Compliance In Focus
Posted by Emily Haglund on Fri, Feb 5, 2016

Sharing of Clinical Trial Data – Considerations for Researchers to Show Their Work...

The sharing of clinical trial data has become an increasingly discussed topic in the scientific community andSharing_of_Clinical_Trial_Data_II could soon create impacts beyond that of scientists that include the public and those that participate in clinical research. The concept focuses on the sharing of clinical trial data that led to conclusions presented in scientific publications. It is a way for researchers and scientists to “show their work” and support how conclusions were reached.

In January 2015, The Institute of Medicine (IOM) released a report on “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.” A summary and public presentation slides are available for review. While data sharing challenges include what types of data to share, when to share, and how to share the information, various benefits are described that include:

  • Other investigators can reproduce published findings, carry out additional analyses
  • Strengthens evidence base for regulatory and clinical decisions
  • Leads to new ideas for research
  • Increases contributions of participants and avoids unnecessary duplicative trials
  • Increases scientific knowledge gained from work of clinical trialists, investments by funders

The IOM’s review and recommendations include specific guiding principles for data sharing that include a detailed discussion on the timing of the data sharing and stakeholder involvement.

In January 2016, the International Committee of Medical Journal Editors (ICMJE) released an editorial that proposes data sharing as a condition of consideration for publication of a clinical trial report in their member journals. The ICMJE proposes that data sharing “will increase confidence and truest in the conclusions drawn for clinical trials” and allow for “independent confirmation of the results.” The ICMJE proposal includes:

  • Requirement for authors to share with others the de-identified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. 
  • The data underlying the results are defined as the IPD required to reproduce the article's findings, including necessary metadata.
  • This requirement will go into effect for clinical trials that begin to enroll participants beginning 1 year after the ICMJE adopts its data-sharing requirements.

The ICMJE indicated these plans and will consider feedback received based on the released editorial.

Data sharing considerations also include ensuring patient confidentiality through unique identifiers and protection of personal health information. This may require appropriate approvals from an Institutional Review Board or Ethics Committee informed consent documentation to ensure patients are informed prior to participation in the clinical trial.

While the widespread implementation of data sharing activities has not yet been fully defined, there are significant stakeholders involved to ensure data sharing is done so in the correct manner to allow researchers the opportunity to show their work.

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photo credit: Research Data Management via photopin (license)

Topics: Institute of Medicine, International Committe of Medical Journal Editors, Clinical Trial Data


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