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Washington Highlights

AAMC Submits Comments to ICMJE on Clinical Trial Data Sharing Proposal

April 22, 2016—The AAMC April 18 submitted comments to the International Committee of Medical Journal Editors (ICMJE) on proposed requirements for sharing clinical trial data. The ICMJE is a working group of leading medical journal editors, which develops recommendations reviewing the conduct and reporting of research in medical journals.

The AAMC commits to the development of a learning health system where both anonymized patient records as well as data from clinical studies are available for research. Specific to the ICMJE proposal, the AAMC supports sharing deidentified individual patient-level data (IPD) from published clinical trials, with appropriate safeguards for protection of patient privacy, assignment of credit to originating investigators, assurance of transparency in how data are used, and other qualifications.

The proposal suggests sharing IPD within six months of publication, however, the AAMC is concerned that the turnaround may not always be the feasible or appropriate, and urges the ICMJE to build some flexibility into this requirement. Finally, the AAMC agrees that authors should include a plan for data sharing as a component of clinical trial registration, and that any data re-use should appropriately recognize and cite the original investigators.   

A Jan. 28 editorial published simultaneously in all ICMJE journals commented on the need for the proposal, stating that “Sharing data will increase confidence and trust in the conclusions drawn from clinical trials… It will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society.”

Contact:

Anurupa Dev, Ph.D.
Senior Science Policy Analyst
Telephone: 202-862-6048
Email: adev@aamc.org

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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org