GlaxoSmithKline to allow greater access to clinical trial data

GlaxoSmithKline announced Thursday that it will allow greater access to its clinical trial data to external researchers, the first major pharmaceutical company to do so. CEO Andrew Witty said the drugmaker has "a responsibility to do all we can...to use our resources, knowledge and expertise to help tackle serious global health challenges," adding that "by being more open with our clinical trial data, we also hope to help further scientific understanding."

Under the initiative, GlaxoSmithKline will allow outside scientists access to "detailed anonymised patient-level data" from clinical studies of its approved drugs and those that have failed in development. The company will form an independent panel of experts to review requests submitted by researchers, with those deemed to have scientific merit permitted to view the data on a secure web site. The policy will apply to clinical trials since 2007 and all clinical studies starting in 2013. GlaxoSmithKline also pledged to publish results of all of its clinical trials, regardless of the findings, in peer-reviewed journals.

Patrick Vallance, president of pharmaceuticals R&D at GlaxoSmithKline, noted that the data would include the complete trial protocol. "We're increasingly realising that the more you can make this an open enterprise, the more likely you are to be able to get an advance which allows you to make a medicine," Vallance commented. Company spokeswoman Sarah G. Alspach added that some other supporting documents would be provided to allow researchers to "understand and navigate the data so they can conduct their research."

Vallance denied that the initiative was a response to past scandals. In July, the company finalised a $3-billion agreement to resolve multiple US government investigations, including allegations that it provided misleading information and withheld other data on drugs including Avandia and Paxil. "It’s absolutely what I’ve believed for a long time," Vallance said, adding that "it’s what Andrew [Witty] believed. It’s what many people in the company believed."

In addition, GlaxoSmithKline said that it will make a library of around 200 internal compounds that have shown activity against tuberculosis freely accessible to outside researchers. The move builds on a similar initiative from 2010 when the company made a library of 13 500 chemical compounds that have the potential to treat malaria available for external researchers.

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