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Sharing clinical trial data should become the “expected norm,” US panel says

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h240 (Published 14 January 2015) Cite this as: BMJ 2015;350:h240
  1. Michael McCarthy
  1. 1Seattle

Investigators, sponsors, and other stakeholders in clinical research should “foster a culture in which data sharing is the expected norm,” a US Institute of Medicine committee has concluded in a report issued on 14 January.1

“The issue is no longer whether to share clinical trial data, but what specific data to share, at what time, and under what conditions,” said Bernard Lo, the committee’s chair and president of the Greenwall Foundation, in the report’s preface.

The Institute of Medicine convened the committee to develop guiding principles and a framework for sharing clinical trial data. The report was sponsored by the National Institutes of Health, the Food and Drug Administration, the Doris Duke Charitable Foundation, the Medical Research Council, the Wellcome Trust, and the Burroughs Wellcome Fund, as well as more than a dozen major drug companies.

Sharing clinical data—allowing investigators to carry out additional analyses and reproduce published findings—is in the public …

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