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‘No consensus’ on transparency

Published on 22/04/13 at 11:35am
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An ABPI meeting on increasing the transparency of the way clinical trials are reported has thrown up more questions than answers, not least in terms of what ‘transparency’ should actually mean.

The half-day workshop was attended by stakeholders including the Department of Health and Wellcome Trust, plus pharma companies including AstraZeneca and Shire, along with Dr Sarah Wollaston, Conservative MP and member of the health select committee.

The first of what the ABPI says will be a series of similar events on the topic, took place last month although a summary of the discussions has only just been released.

There is a “lack of consensus on the degree of disclosure required to constitute transparency”, ABPI suggests.

This will not be news to Ben Goldacre, author of Bad Pharma, or the British Medical Journal and the Cochrane Collaboration, which have repeatedly called on Roche to release more data on Tamiflu.

Pressure has also been applied by the AllTrials initiative - dismissed by the ABPI as ‘PR-driven’ - which wants trials to be registered and the disclosure of their results plus clinical study reports to help improve transparency and aid research.

“There is a widespread recognition that greater transparency in clinical trial reporting could provide health benefits, and that the pharmaceutical industry should not be immune from wider social trends towards openness and scrutiny,” the ABPI acknowledges.

But there are many stumbling blocks, it goes on, including what should be done about the thousands of past trials whose data may be stored on media which is no longer easily accessible.

Other problems include the standards of patient confidentiality that should be applied, the procedures that academic-sponsored trials should follow and how to interpret ‘informed consent’ for retrospective trials, the ABPI workshop found.

The information needs of different users of the data - particularly those involved in systematic reviews and meta-analyses - were also questioned, as were the technical issues which could limit the aggregation and analysis of data across trials.

The issue of what definition of ‘transparency’ should be used was also highlighted: European pharma trade body EFPIA has consistently warned against the ‘indiscriminate’ release of data, and ABPI says it wants any future action “implemented in a manner that supports good research, with data being analysed and interpreted appropriately”.

Patient confidentiality, scientific integrity and the protection of intellectual property rights are perhaps the three main issues over which pharma and its critics will clash. “Practical and technical issues may further limit what can be achieved in practice,” ABPI warns.

Adam Hill

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