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IOM looks into new ways to share clinical trial data

By Zachary Brennan , 30-Jan-2014

The Institute of Medicine is conducting a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data before a final report is released in December 2014.

According to the framework for the discussion , the IOM is looking to learn and understand what ways clinical trial data can be further shared as the data can be crucial to not only the researchers and CROs, but patients and others who volunteer and participate.

Clinical trials are crucial to determining the safety of medical interventions and their ability to achieve particular health outcomes and represent a significant investment from all involved — patients and others who volunteer to participate, organizations that sponsor trials, and the researchers who conduct a study and analyze the data,” the IOM says.

However, the institute notes that much of the data generated by clinical trials is not public or shared beyond the data holder, and significant barriers to sharing these data exist.

The IOM is focusing its efforts on how different types of data might be prioritized for sharing and the rationale behind releasing certain types of data; how to minimize the public risk from invalid analyses of data and any privacy risks; what identifiable data needs to be released; how incentives can be used to encourage CROs and investigators to continue conducting research; and finally, appropriate outcome measures to gauge how future research should be shared.

The interim report produced from the study will be released for public comment in January 2014 and will include tentative findings on guiding principles that “underpin responsible sharing of clinical trial data and a characterization of a selected set of data and data sharing activities (to clarify definitions and develop a shared nomenclature).”

Based on public comment on the interim report and on further deliberations, the committee will prepare a final report with findings and recommendations on the benefits and risks of sharing and not sharing clinical trial data and on the different types of opportunities to improve responsible sharing of clinical trial data. The anticipated release date for the final report is December 2014.

The committee will meet approximately five times over the course of the study. Two public workshops convened in conjunction with committee meetings are tentatively scheduled for late winter and spring 2014. 

As required in the charge to the committee, Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities  is being released for public comment and should be submitted by March 24, 2014.

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