Bristol-Myers Squibb is collaborating with Duke University through its Duke Clinical Research Institute (DCRI), focusing on clinical trial transparency. BMS 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, BMS.
BMS also will publish CSR synopses at http://bms.com/clinical_trials/ for studies that support a product’s marketing authorization application to the FDA or the EMA shortly after the regulatory approval of the product has been granted. The company also has 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. BMS is working with various industry groups and regulators to evaluate the most effective method to deliver this level of detail to patients.
DCRI faculty members will be an independent scientific review committee to evaluate data requests and their accompanying research proposals from qualified scientific and medical researchers seeking access to clinical trial information from BMS-sponsored trials, and make final decisions on data sharing. Proposals will be evaluated based on the scientific rationale for the research as well as plans for statistical analyses and publication.
BMS’ existing policy on disclosure of clinical trial information includes registration of all phase I, II, III and IV interventional trials in which BMS has responsibility, and open and timely reporting of results, regardless of outcome, from sponsored clinical trials involving BMS marketed products through scientific congresses or publication in peer-reviewed journals.
BMS’ policy on data sharing is aligned with the Principles for Responsible Clinical Trial Data Sharing released by the U.S. and European pharmaceutical trade associations, PhRMA and EFPIA, by which biopharmaceutical companies pledge their commitment to enhancing public health through responsible sharing of clinical trial data consistent with safeguarding patient privacy and informed consent, respecting the integrity of national regulatory systems and maintaining incentives for investment in biomedical research.
