Open Data and Clinical Trials

Editorial by Jeffrey M. Drazen, M.D at :”In the fall of 2013, the Institute of Medicine (IOM) convened a committee, on which I serve, to examine the sharing of data in the setting of clinical trials. The committee is charged with reviewing current practices on data sharing in the context of randomized, controlled trials and with making recommendations for future data-sharing standards. Over the past few months, the committee has prepared a draft report that reviews current practices on data sharing and lays out a number of potential data-sharing models. Full details regarding the committee’s charge and the interim report are available at….
Open-data advocates argue that all the study data should be available to anyone at the time the first report is published or even earlier. Others argue that to maintain an incentive for researchers to pursue clinical investigations and to give those who gathered the data a chance to prepare and publish further reports, there should be a period of some specified length during which the data gatherers would have exclusive access to the information. Since these researchers could always agree to collaborate with others who were not involved in the study in order to use the data to help answer a scientific question, the period of exclusivity would really apply only to noncollaborative use of the data. That is, there would be a defined period during which the data would not be available to those who wanted to perform their own analyses and draw conclusions that could, for example, provide them with a scientific or commercial competitive advantage over the researchers who had originally gathered the data or allow them to derive conclusions that are potentially at odds with those drawn in the original publication.
As members of a community that either produces or uses data, what approach do you think serves our community best? There is no need to reply to the Journal, but please read the interim report and let the IOM know how you feel about this and the many other critical issues related to data sharing that are reviewed in the document. The IOM is collecting comments until March 24, 2014, at”