Bristol-Myers Squibb (BMY) has announced a collaboration with Duke University through its Duke Clinical Research Institute (DCRI) 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 company’s 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 (CSR) 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’s collaboration with DCRI reflects our commitment to providing broader, more timely access to important clinical trial information and serves as a catalyst to strengthening public confidence in medicines, advancing science and improving public health," said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb.
"This program is a great leap forward for open science and is highly consistent with the DCRI’s mission to develop and share knowledge that improves the care of patients around the world through innovative clinical research," said Eric Peterson, M.D. MPH, Executive Director of the DCRI.
Bristol-Myers Squibb will also publish CSR synopses at http://bms.com/clinical_trials/Pages/home.aspx for studies that support a product’s 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.