While the debate over how to implement clinical trial data transparency laws rages in Europe, Big Pharma firms continue to roll out their own offerings, with Bristol-Myers Squibb ($BMY) the latest to show its hand. And the U.S. drugmaker has gone further than some of its peers by handing over decision-making powers to a third party and promising to publish full clinical study reports (CSR).
The arrangement is reminiscent of Johnson & Johnson's ($JNJ) partnership with Yale School of Medicine, which saw the healthcare giant give its academic ally the final say on when to share data. In Bristol-Myers' case, the third party is Duke University, specifically the Duke Clinical Research Institute (DCRI). Members of the DCRI faculty will form an independent review panel to assess applications from researchers who want Bristol-Myers' data. The panel has the final decision.
As in the J&J-Yale partnership, just how open DCRI is with its partner's data will depend on the criteria on which it bases its decisions. Even so, Bristol-Myers' commitment goes beyond the actions of some of its peers. Pfizer ($PFE), for example, is only sharing summaries of CSR, a decision that prompted criticism from trial transparency campaign group AllTrials. Bristol-Myers will make full CSR and de-identified patient-level data available, but only for trials completed after 2008.
The limited time frame means CSR for many of Bristol-Myers' best selling drugs--such as the blockbuster antipsychotic Abilify and hepatitis B powerhouse Baraclude--will stay hidden. Over time, though, CSR for a greater a greater proportion of Bristol-Myers' portfolio will become available, with key trials for Yervoy and other drugs ending after the 2008 cutoff date.
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