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J&J reveals more on transparency policy

Published on 03/02/14 at 01:24pm
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Johnson & Johnson’s pharma subsidiary Janssen has given Pharmafile more details on its new transparency policy, which will see both historical and future data made available to third parties.

Last week the firm announced that it would allow Yale University’s Open Data Access (YODA) project to independently grant access to its archive of clinical research findings.

There are however, some limitations: the application website outlines some of the reasons requests may be turned down, including “whether it is feasible to ensure the privacy and confidentiality of research participants” and “whether the studies have been published or accepted for publication”.

Janssen EMEA company group chair Jane Griffiths, told Pharmafile that applicants also need to show that they are investigating “a legitimate scientific question that’s being asked for the advancement of science and the improvement of healthcare”. 

It is up to an independent panel at Yale to determine whether or not requests are up to scratch, although Griffiths confirmed that YODA may consult Janssen “if they feel a request is unusual”.

Janssen executives also informed Pharmafile that the company will pay Yale for its services - but they were unable to give precise figures. 

The firm’s EMEA VP of communications and public affairs, Stefan Gijssels, said: “Yes, we are compensating YODA for undertaking the administrative and review role for our data sharing process.  

“We made an estimate of the volume of work that might be required and will adjust as this becomes clearer with time. However, payment to the external steering committee members whom YODA will choose as consultants for the review process will be paid by YODA at their discretion.”

Gjissels went on to confirm that Yale will log requests and decisions online, and that the rationale for any rejections will also be made public. 

Transparency has been an industry hot topic for well over a year now, with groups such as the AllTrials campaign calling on pharma companies to register clinical studies and report all results.

Some firms such as GSK have taken steps to make research finding more available to the scientific community, but Janssen has gone further by allowing an independent body to make decisions on data access. 

When asked if she believed other companies would follow suit, Griffiths responded: “That’s difficult to say. There are discussions in pharma at the moment about what level of transparency should be the industry standard. This is what J&J have decided to do - it’s up to other companies to decide what they want to do.” 

Although her firm appears to be taking a progressive approach to transparency, Griffiths stopped short of saying it will give its backing to AllTrials, but added: “I think we have shown that we’re aligned with the principles of AllTrials anyway with what we’ve done.” 

Griffiths concluded: “I’m proud the company has taken this step; it’s important that we can be seen to be move forward on transparency - for the advancement of science and for building reputation and trust with key stakeholders.

“I have to say that in the last couple of days we’ve had some very genuine feedback congratulating us, which I think illustrates that it’s been a good thing to do.” 

Hugh McCafferty

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