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J&J sets new pharma standard for sharing clinical trial data

Chooses Yale to act as independent trial data request review body
Johnson & Johnson headquarters

Johnson & Johnson (J&J) has enlisted Yale University to review requests from researchers to access clinical data held by its pharma business Janssen.

Yale, through its Yale School of Medicine's Open Data Access (YODA), will act as an independent body to review and make final decisions regarding all requests for Janssen's clinical trial data for its treatments, including clinical study reports (CSRs) and de-identified patient-level data.

J&J also announced a new website at www.clinicaltrialstudytransparency.com to assist researchers in request for data.

It is the first time a pharma company has taken the step to introduce a third party as an independent reviewer as pressure grows on the industry to improve transparency of drug data following concerns that some drugs, such as Roche's Tamiflu, were not as effective as their manufacturers claimed.

This campaign has been led by the AllTrials group, which counts Germany's IQWIG, GlaxoSmithKline (GSK) and the National Institute for Health and Care Excellence (NICE) among its supporters.

In its comment on J&J's announcement, AllTrials quotes Richard Lehman – an adviser to the YODA project – who described the move as a “game-changer” for pharma.

He said: “The project will be wide open and will provide help to companies who want to follow in J&J's footsteps. It will leave organisations who are still discussing whether data sharing is even a good thing looking very out of date.”

Other companies making headway in improving transparency include GSK, which along with joining the AllTrials campaign, has set up an online system to provide researchers with access to anonymous patient-level data about its medicines.

And just last week, GSK's director of scientific and public disclosure Tatjana Poplazarova announced the company was looking to establish an 'independent data custodian' to handle data sharing requests, with a view to sharing this custodian with other pharma companies to ensure efficiency.

J&J is the first company to take the plunge, however, with chief medical officer Dr Joanne Waldstreicher explaining the company's decision represented a “new standard for responsible, independent clinical data sharing”.

She added: “Sharing anonymised data from clinical trials is critical to advance public health because it furthers our understanding of diseases, expands the base of knowledge needed to develop new treatments, and generates new insights and more complete evidence to enable better healthcare decisions for patients - all while protecting patient privacy and confidentiality.”

As for how the collaboration with Yale will work in practice, J&J said that YODA members may reach out to Janssen researchers with questions during its review of a request, but the final decision on data sharing will be made by YODA.

Members of the YODA team can also select and appoint an independent external panel of non-Janssen experts to help assess requests in some cases.

J&J's plans don't just stop with pharma products, however, and the company intends to introduce data sharing process for its medical device and consumer products.

31st January 2014

From: Research, Healthcare

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