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June 24, 2014
08:01 EDTBMYBristol-Myers expands access to clinical trial data through DCRI collaboration
Bristol-Myers Squibb announced a collaboration with Duke University through its Duke Clinical Research Institute focused on clinical trial transparency. Bristol-Myers Squibb will expand access to a broader set of clinical trial information from in-scope company-sponsored studies and enable an independent scientific review through DCRI of requests from researchers that meet pre-specified requirements. The collaboration with DCRI is one of a series of initiatives by Bristol-Myers Squibb to support data sharing and enhance the companyís existing policies on transparency and disclosure of clinical trial information. Clinical trial information being made available for scientific research will include protocols, full clinical study reports and de-identified patient-level data and study-level data for medicines and indications approved in the U.S. and/or Europe for trials completed after January 2008. Information from terminated programs will be available two years after discontinuation. Bristol-Myers Squibb will also publish CSR synopses for studies that support a productís marketing authorization application to the U.S. Food and Drug Administration or the European Medicines Agency shortly after the regulatory approval of the product has been granted. The company has also committed to provide lay-language summaries of clinical trial results for patients who participated in clinical trials and wish to receive a summary of the aggregate study level results. Bristol-Myers Squibb is working with various industry groups and regulators to evaluate the most effective method to deliver this level of detail to patients.
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