N Engl J Med 2017; 377:1990-1992November 16, 2017DOI: 10.1056/NEJMsb1708278
"The Wellcome Trust, the Medical Research Council, Cancer Research UK, and the Bill and Melinda Gates Foundation share a common vision for maximizing the value of data that are generated through the trials we fund. We are committed to ensuring that the data from published clinical trials can be accessed by researchers so they can validate key findings, stimulate further inquiry, and ultimately deliver lifesaving results."
"As funders of medical research, we recognize the importance of the appropriate sharing of clinical-trial data for reasons of transparency, good practice, and accelerated dissemination of results to the broader community. There is now a clear consensus that the results of all clinical trials must be reported in a timely manner, as set out in a joint statement by the World Health Organization regarding public disclosure of results from clinical trials.4 In addition, all our organizations have implemented data-sharing policies requiring that the data from studies we have funded will be made available to other researchers at the time of publication. This requirement applies equally to clinical trials.
These policies, however, do not mean that such data have to be openly available for anyone to access on the Web. We fully recognize that some data — and especially clinical-trial data — may contain sensitive, personal information about research participants, and these data need to be shared in a manner that protects participants’ privacy and confidentiality and respects the terms under which they consented to take part in the study. Such an approach might include the use of managed-access procedures, whereby requests to access data are reviewed by an independent committee, and of data-access agreements that place appropriate restrictions on how the data may be used."
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