Novartis joins GSK, Sanofi in opening some drug trial data to researchers
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New York — Novartis AG will join companies such as GlaxoSmithKline and Sanofi in allowing researchers access to clinical trial data, as regulators demand more transparency.
Researchers will be able to request information on medicines that were newly approved in the U.S. and the European Union via an Internet portal, Novartis said in an e-mailed statement today.
Novartis’s plan doesn’t include access to older data. Drugmakers including GlaxoSmithKline (NYSE: GSK), the U.K.’s largest, and Paris-based Sanofi have proposed greater disclosure of test results for medicines. Those plans don’t go far enough because they don’t cover many past trials, which are relevant to products currently in use, the U.K.’s House of Commons Committee of Public Accounts said in January.
“Opening up information about all clinical trials to medical researchers would support the work of regulators by permitting thorough, independent external review by doctors and researchers,” the committee said in a report.
The data can’t be traced back to individual patients, and data from small trials in rare diseases will not be provided to assure anonymity, Anja von Treskow, a spokeswoman for Novartis, said in an e-mail.
The Internet portal also handles requests for Sanofi and Glaxo, among others. A panel of four reviewers decides on granting access to the data, according to the website.
While the U.S. has required the registration of clinical trials since 1997, drugmakers still have wide latitude on deciding what data from those tests they will disclose to the public.
The European Medicines Agency last year released a draft policy on publication of clinical trial data, a step designed to improve transparency that affects all drugmakers seeking permission to sell their medicines in the European Union. The move has sparked debate throughout the pharmaceutical industry.
Von Treskow declined to comment when asked if Novartis’s plan is a reaction to the EMA’s draft guidance.
[Novartis operates a huge vaccine facility in Holly Springs, N.C. and also conducts research and development at the complex.]
[GSK operates its North American headquarters in RTP.]
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