Bristol-Myers Squibb Expands Access to Clinical Trial Data Through Collaboration with Academic Research Institute
June 24 2014 - 8:00AM
Business Wire
Bristol-Myers Squibb (NYSE:BMY) today 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.
DCRI is the world's largest academic clinical research
organization 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. The
Bristol-Myers Squibb company website will disclose the names of
faculty members of the DCRI review board, all proposals and summary
statements from the review. Scientific and medical researchers can
submit requests for access to data on Bristol-Myers Squibb’s
company website at
http://bms.com/clinical_trials/pages/disclosure.aspx.
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. In addition, the company submits trial results to be made
available on the National Institutes of Health website at
www.ClinicalTrials.gov, and other similar databases required by
other regulatory agencies.
Bristol-Myers Squibb’s 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.
Information on Bristol-Myers Squibb’s policy on disclosure of
clinical trial information can be found at
http://bms.com/clinical_trials/pages/disclosure.aspx.
Facilitation of this program 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
organizations.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information, please visit www.bms.com or follow us on
Twitter at http://twitter.com/bmsnews.
Media:Bristol-Myers SquibbLaura Hortas,
609-252-4587laura.hortas@bms.comorKen Dominski,
609-252-5251ken.dominski@bms.com
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