Bristol-Myers enlists Duke's CRO to help it share trial data

Bristol-Myers Squibb ($BMY) has tapped Duke University's in-house CRO to pitch in on clinical trial transparency, asking the organization's researchers to independently review requests for shared data.

Under the collaboration, the Duke Clinical Research Institute will field pitches from outside researchers, weighing them against Bristol-Myers' pre-specified criteria and making the final call on whether to hand over data. DCRI faculty will serve on a review committee, convening experts in biostatistics, research ethics and patient privacy, judging requests by scientific merit and commitment to open science.

At stake are protocols, full clinical study reports and anonymized patient-level data. Bristol-Myers is willing to share post-2008 results from studies on drugs approved in the U.S. or Europe, and it's also handing over data on terminated projects two years after their discontinuation.

Bristol-Myers is following the sweeping trial transparency trend among pharma giants, and its move to outsource the dispersal of data takes it further than the many companies looking just to comply with changing regulations in Europe.

"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," Chief Scientific Officer Francis Cuss said in a statement.

For Duke, the agreement follows a slew of trial-based collaborations with the industry. In December, Oxygen Biotherapeutics ($OXBT) reached out to DCRI to handle late-stage studies of its promising heart drug, following an August agreement with the International Stem Cell Corporation ($ISCO) for early-stage Parkinson's work and a March handshake with Benitec Biopharma to run Phase I/II trials for an RNAi hepatitis C drug.

The school's CRO has more than 150 studies under its belt, and Duke bills DCRI as the only university-based contractor that can provide all the services of a large CRO backed up with the academic credibility of a top-tier research institute.

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