Bristol-Myers Squibb 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 programme 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 for studies that support a product’s marketing authorisation application to the US 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.
DCRI is the world's largest academic clinical research organisation with more than 40 years of experience conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. DCRI faculty members will serve as 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 Bristol-Myers Squibb-sponsored trials, and make final decisions on data sharing.
These reviews will be conducted by a panel of experts in biostatistics, research ethics and patient privacy, and the clinical specialty of the research. Proposals will be evaluated based on the scientific rationale for the research as well as plans for statistical analyses and publication.
Bristol-Myers Squibb’s existing policy on disclosure of clinical trial information includes registration of all Phase I, II, III and IV interventional trials where BMS has responsibility, and open and timely reporting of results, regardless of outcome, from sponsored clinical trials involving Bristol-Myers Squibb marketed products through scientific congresses or publication in peer-reviewed journals.
Bristol-Myers Squibb’s policy on data sharing is aligned with the Principles for Responsible Clinical Trial Data Sharing released by the US 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.
Facilitation of this programme was enabled through existing legal infrastructure and relationships within the Bristol-Myers Squibb - Duke Translational Medicine Institute Strategic Collaboration. This partnership was announced in March 2012 with the goal of increasing collaboration between the two organisations.