Preparing for responsible sharing of clinical trial data.


Data from clinical trials, including participant-level data, are being shared by sponsors and investigators more widely than ever before. Some sponsors have voluntarily offered data to researchers, some journals now require authors to agree to share the data underlying the studies they publish, the Office of Science and Technology Policy has directed federal agencies to expand public access to data from federally funded projects, and the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) have proposed the expansion of access to data submitted in regulatory applications. Sharing participant-level data may bring exciting benefits for scientific research and public health but may also have unintended consequences. Thus, expanded data sharing must be pursued thoughtfully.

DOI: 10.1056/NEJMhle1309073
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@article{Mello2013PreparingFR, title={Preparing for responsible sharing of clinical trial data.}, author={Michelle Marie Mello and Jeffrey K Francer and Marc Wilenzick and Patricia Teden and Barbara E. Bierer and Mark Barnes}, journal={The New England journal of medicine}, year={2013}, volume={370 5}, pages={484-5} }