BMS expands data transparency
pharmafile | June 27, 2014 | News story | Medical Communications, Sales and Marketing | BMS, best electronic cigarettes, csr, dcri, transparency
Bristol-Myers Squibb is to expand access to its clinical trial data – but researchers’ requests will have to be approved by an academic body.
An independent scientific review by Duke University’s Duke Clinical Research Institute (DCRI) will determine whether such requests ‘meet pre-specified requirements’.
Despite these limitations, BMS is trumpeting the move as enhancing its “existing policies on transparency and disclosure of clinical trial information”.
“BMS’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,” insists Francis Cuss, BMS chief scientific officer.
Trial information which will be available for scientific research is to include protocols, full clinical study reports (CSR) and ‘de-identified’ patient-level and study-level data for drugs approved in the US and Europe for trials completed after January 2008.
BMS promises that data from programmes which have been abandoned will be in the mix two years after discontinuation.
“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,” says Eric Peterson, executive director of the DCRI.
BMS says it will also publish CSR synopses online for studies supporting a product’s marketing authorisation application to the US Food and Drug Administration, or the European Medicines Agency (EMA) “shortly after the regulatory approval of the product has been granted”.
It has also committed to providing what it calls ‘lay-language summaries’ of trial results for patient participants.
Transparency of clinical trial data is en vogue in pharma at present – not least in Europe because the adoption in the European Parliament of the new Clinical Trials Regulation, which will come into force in 2016, demands it.
The EMA is to formally agree its policy on the issue, including what it calls ‘more ‘user-friendly’ amendments which would allow users to download, save and print trial data for “academic and non-commercial research purposes”.
Adam Hill
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