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UPDATED: J&J in ‘game-changing’ data disclosure plan

Published on 30/01/14 at 08:37am
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The US drug giant Johnson & Johnson will become the first pharma company to give academic researchers both full and free access to its clinical trial data.

The new collaboration with Yale University’s Open Data Access Project, or YODA, was announced this week and allows the project the power to release years of J&J drug findings to outside researchers.

Harlan Krumholz, the Yale researcher leading the project, said it will “open up a world of information about how drugs work, and their risks and benefits”.

With YODA, researchers will have the opportunity to look further into J&J’s data and will likely include new information that the firm had not previously published. Researchers can then search the data to see which patients benefit from a drug the most, or for side effects that are more common in one group or another.

To get the data, researchers will apply to the YODA programme and then a board composed of non-J&J advisers will review requests and decided whether to release the information, the company said in a statement.

If approved by YODA or the board, the researchers will get access to detailed data to the level of the individual patient - but the company stresses that the patients’ privacy ‘will be protected’.

A spokesman for the firm told Pharmafile: “This is the first time any company has collaborated with a completely independent third party to review and make final decisions regarding every request for clinical data, and we believe it sets a new industry standard in ensuring all requests for clinical data are reviewed in a systematic and objective way that protects patient privacy and confidentiality.”

He went on: “We believe that responsible sharing of anonymised clinical trials data enhances public health and advances science and medicine and is in the best interest of the nurses, patients, mothers and fathers and all others who use our products.

“As such, we support the overall PhRMA-EFPIA principles of greater clinical trial data transparency and sharing, including registration and disclosure of clinical trial results in external registries, publication of results in peer reviewed journals, and sharing of Clinical Study Reports (CSRs).  Our companies have collaborated with researchers who have made requests for our clinical data on an individual basis.”

Under the agreement with YODA, the firm will now be able to share data from its clinical trials in the form of CSRs and participant level data in a systematic and objective way that the company hopes will “advance medicine and scientific knowledge while protecting patient privacy”.

Follow the leader?

It is also hoped that other pharma companies may follow suit as the global pressure on companies to release their trial data has been increasing over the past two years. This is because the industry has not been disclosing all of its data, leading to researchers, doctors and now the public to question why some studies are being held back.

In the US, the law has required the registration of clinical trials since 1997, but pharma can still decide what it wants the public to see - or not to see. This new tact by J&J will go some way to ending this criticism, and allow greater scrutiny of its medicines.

Krumholz told Bloomberg: “There are great insights that are residing within these data. It really will be game-changing.”

The increased transparency may prompt other drugmakers to do the same. Krumholz told Bloomberg that he has reached out to other companies before and some “are reluctant to give up the control”, but stopped short of naming the firms.

The first company to make some steps toward greater disclosure has been GSK that, in March last year, signed the campaign group AllTrials’ register indicating its willingness to share more data.

But this is not going as far as J&J because researchers have to first go through the firm - if GSK doesn’t support the request, it will then be up for negotiation and the company holds the right to block access.

Pfizer said in December that it too would broaden access to information from its clinical trials to independent researchers and to patients who take part in the studies. The US giant also set up an independent review panel of academic scientists to decide which researcher requests it would answer.

Having an independent body managing the release of the data is important, Krumholz said. In J&J’s case, it means the company wouldn’t be able to slow or stop a request that could have a negative effect, an option still available to GSK.

“We have nothing to hide and if new findings come out - positive or negative - all the better,” said Joanne Waldstreicher, J&J’s chief medical officer.

He added that J&J plans to open up medical device and consumer health product information to YODA.

Ben Adams

 

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