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Novartis commits to greater transparency on trials

Will provide anonymised patient-level data but only for new studies

NovartisNovartis has joined a number of its peers in the pharma industry by agreeing to provide access to anonymised patient-level data from clinical trials.

Like fellow drugmakers Boehringer Ingelheim, GlaxoSmithKline, Roche, Sanofi and ViiV Healthcare, Novartis will provide access to the data using a portal developed by ideaPoint that is used by researchers to ask for data access and by the companies to evaluate the validity of the requests.

"Novartis has long supported data transparency and was the first company to publish positive and negative study results of its innovative medicines within one year of the study completion further enabling clinical research while protecting patient privacy," claims the company.

In addition to research proposals to request data from trials already listed on the site, using ideaPoint researchers can also submit inquiries to some study sponsors to ask about the availability of data from other studies.

Novartis has also said it intends to provide plain language Clinical Study Reports (CSRs) for all new pivotal studies, along with new interpretations of the data, by the end of the year. The company already makes public summaries of CSRs on its innovative medicines through its portal, and to date has published 1,777 redacted CSRs.

A similar commitment on CSRs was announced by Pfizer last December, although transparency advocates - including the AllTrials campaign - have suggested the measures being proposed by pharma companies do not provide enough detail about trials or go far enough back in time.

For example, a study by researchers at German health technology assessment (HTA) agency IQWiG concluded that summaries of trials made available by pharma companies often lack vital details on the effects and side effects of medicines which feature in the full CSRs.

Last month, Johnson & Johnson took the transparency drive step further by saying it would provide access to all its patient data from pharma clinical trials to researchers at the Yale University Open Data Access (YODA) project.

That move was warmly received by Alltrials, which described it as "a great step forward for access to clinical trial data".

Article by
Phil Taylor

27th February 2014

From: Research



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