Trial data transparency under fire from UK parliamentary committee
An influential group of MPs forming Parliament’s Public Accounts Committee has strongly criticised pharmaceutical companies and UK health regulatory bodies over the extent and transparency of practices for sharing information from clinical trials.
The report, “Access to clinical trial information and the stockpiling of Tamiflu”, included evidence from the Department of Health, the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), campaigner Dr Ben Goldacre and Dr Fiona Godlee, editor-in-chief of the British Medical Journal.
One of the committee’s MPs, Richard Bacon, said the committee was “extremely concerned” that research suggested probably half of clinical data were not published.
Mr Bacon noted that regulators and industry had made recent proposals to open up access, but that these did not cover the results of past trials that “bear on the efficacy and safety of medicines in use today“.
He said the committee was also concerned about the amount of data being shared between UK regulators.
“There is no routine sharing between NICE and the MHRA of information provided by manufacturers during the process of licensing medicines.
“There is still a lack of consensus over how well the antiviral medicine Tamiflu, stockpiled for use in an influenza pandemic, actually works.
“The lack of transparency of clinical trial information on this drug to the wider research community is preventing proper discussion of this issue among professionals.
“We are disturbed by claims that regulators do not have access to all the available information.”
Richard Bacon, member of the UK Parliament and of the Committee of Public Accounts.
Concerns raised over “withheld” clinical trial results (Nursing Times).
Drug companies ‘witholding research’ from doctors, MPs warn (The Telegraph).
The availability of clinical trial results and the sharing of information between the MHRA and NICE, in the UK Public Accounts Committee 35th report, “Access to clinical trial information and the stockpiling of Tamiflu”.
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