26 Jun 2014, BioSpectrum Bureau , BioSpectrum
Singapore: Bristol-Myers Squibb is looking forward to bring more transparency in its clinical trials and has partnered with Duke Clinical Research Institute (DCRI) whose faculty members will serve as an independent scientific review committee to evaluate data requests and their accompanying research proposals by scientific and medical researchers seeking access to clinical trial information from Bristol-Myers Squibb-sponsored trials.
BMS mentioned that the collaboration is to support data sharing, transparency and disclosure of clinical trial information available for scientific research and 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 US and/or Europe for trials completed after January 2008.
"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 Mr Francis Cuss, 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 Mr Eric Peterson, executive director, 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 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.