Bristol-Myers Squibb Collaborates With Duke University On Data Transparency

Bristol-Myers Squibb announced that it has entered into collaboration focused on clinical trial transparency with Duke University’s Clinical Research Institute (DCRI).

The agreement is one of a series of initiatives launched by BMS to promote data sharing and improve its existing policies on transparency and clinical trial information disclosure. As part of the agreement, BMS will expand access to a wider set of clinical trial data from company-sponsored trials, as well as protocols and anonymous patient and study level data from FDA/EU drug-approval trials conducted within the last five years. This move should enable researchers who meet pre-specified requirements to conduct scientific review through DCRI requests. The company also says it will share data from discontinued trials for a span of two years after the end of the trial.

BMS will also publish CSR synopses at its webpage for studies that form the basis for a drug’s marketing authorization application to the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) shortly after its approval.

Francis Cuss, EVP and CSO of Bristol-Myers Squibb, said, “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.”

Eric Peterson, Executive Director of the DCRI, said, “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.” Indeed, BMS is jumping on the bandwagon with several other big drug companies, including Boehringer Ingelheim, Bayer, and Eli Lilly, that have recently announced they, too, are launching new initiatives to ensure that interested parties have access to their data.

DCRIS is the largest academic clinical research organization in the world conducting multinational clinical trials, managing major national patient registries, and working on landmark outcomes research.

The new program was made possible through the existing legal infrastructure and relationships within the Bristol-Myers Squibb - Duke Translational Medicine Institute Strategic Collaboration, announced in March 2012.