DURHAM, N.C. -- Duke University, through its Duke Clinical Research Institute (DCRI), announced this week it has entered into a novel collaboration with Bristol-Myers Squibb (BMS) to promote open access to clinical information from company-sponsored studies.
The purpose of the collaboration is to support BMS’s expanded transparency and leverage existing resources to advance scientific discovery and improve public health. BMS’s efforts 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 DCRI will also review the final manuscripts produced from the data for scientific integrity and consistency with the original proposed work.
DCRI’s executive director, Eric Peterson, M.D., MPH, and its director of biostatistics, Michael Pencina, Ph.D., will oversee the independent review process.
“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,” Peterson said.
“We are excited to be a part of this important initiative, helping not only increase research transparency but also promote its quality,” Pencina said.
“We believe our commitment to providing broader, more timely access to clinical trial information through this collaboration with the Duke Clinical Research Institute can serve as a model for strengthening public confidence in medicines, as well as advancing science and improving public health,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer of BMS.
Researchers may request clinical trial data on any BMS-sponsored interventional studies on medicines approved in the U.S. and/or European Union and completed after January 2008. Requests will be submitted through a BMS-hosted website, which will be forwarded to the DCRI for review by the independent scientific review committee.
The committee will include experts in biostatistics, research ethics, patient privacy, and the clinical specialty of the research. Proposals will be evaluated based on their scientific rationale as well as their analysis plans. The website will include a public listing of the members of the review committee, all proposals and summary statements from the review.
“We recognize the challenges faced by industry when deciding to make data available for secondary analysis,” Peterson said. “We applaud BMS’s efforts toward greater transparency.”
Facilitation of this program was enabled through existing relationships within the Bristol-Myers Squibb-Duke Translational Medicine Institute Collaboration that was announced in March 2012 with the goal of increasing cooperation between the two organizations.