Duke University, through its Duke Clinical Research Institute (DCRI), has entered into a collaboration with Bristol-Myers Squibb (BMS) to promote open access to clinical information from company-sponsored studies.
The purpose of the collaboration is to support BMSs efforts at expanded transparency and leverage existing resources for scientific discovery and improve public health, according to the company. BMSs efforts will increase access to a broader set of clinical trial information from in-scope, company-sponsored studies and enable independent scientific review through DCRI of requests from researchers that meet pre-specified requirements. The DCRI will also review the final manuscripts produced from the data for scientific integrity and consistency with the original proposed work.
Researchers may request clinical trial data on any BMS-sponsored interventional studies on medicines approved in the U.S. and/or European Union and completed after January 2008. Requests will be submitted through a BMS-hosted website, which will be forwarded to the Duke team for review by the independent scientific review committee.
The committee comprises experts in biostatistics, research ethics, patient privacy, and the clinical specialty of the research. The website will include a public listing of the members of the review committee, all proposals and summary statements from the review.
DCRIs executive director, Eric Peterson, M.D., and its director of biostatistics, Michael Pencina, will oversee the independent review process.
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