GSK to open clinical data vaults to scientists via website

GlaxoSmithKline ($GSK) committed to provide researchers with unmatched access to patient-level data from its clinical trials--including studies that failed. The move is among several steps the London-based drug giant announced today to promote open innovation and collaboration with external groups. Yet commentators are skeptical about whether fellow drugmakers will be as bold in opening their data vaults to outsiders.

While GSK is taking an unprecedented step to make its clinical trial data transparent, not everyone is likely to gain unfettered access to its clinical trials info. Glaxo is forming a panel to judge the scientific merit of requests for the anonymous patient data, which is far more detailed than any of the clinical trial information and results posted on the company's website.

Glaxo CEO Andrew Witty announced the plans at an event hosted by the Wellcome Trust, the U.K. charity that has been pushing for researchers to make data from their studies available to all rather than in restricted-access journals. Witty said in prepared remarks: "As a truly global healthcare company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges. However, the complexity of the science and the scale of the challenge mean that we cannot solve these problems alone."

As part of the effort, GSK is publishing data on 200 compounds with promising anti-tuberculosis (TB) properties to spur further research on drugs against the infectious threat to global health. The move builds on its previous work with outside groups to promote R&D on malaria and other diseases affecting developing countries.  

India's government has also funded an open innovation effort to develop TB drugs, providing online tools and a website that fosters collaboration among researchers. Yet in adding access to the patient-level data from trials, GSK is taking its open innovation drive much further than any of its pharma company peers.

There may be no link between the transparency push and making amends for the Avandia disaster and other missteps, but GSK appears to be much more willing to allow external researchers--even those who could harp on side effects--scrutinize its clinical data.

- here's the release
- check out the Forbes article
- and the piece from FierceBiotech

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