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Grant NICE greater trial data access – report

pharmafile | May 29, 2013 | News story | Research and Development, Sales and Marketing Goldacre, NICE, transparency, trials 

A new report by the National Audit Office says NICE should be given greater powers to access clinical trial data.

Currently, the Institute has no automatic access rights to data submitted by pharma to either the EMA or MHRA – but new powers proposed by the NAO would change that.

The reports makes clear that it believes NICE, the MHRA and the EMA should work together to allow NICE access to evidence underlying regulatory decisions, in order to remove the potential for gaps being found.

This could stop the UK government from spending large amounts of money on a drug that may not be value for money, it concluded.

The NAO found the government spent nearly half a billion pounds stockpiling Roche’s influenza drug Tamiflu, despite groups such as the Cochrane Collaboration saying there is not enough data to know whether it is value for money.

NICE declared the drug a cost effective use of NHS resources in 2003, but doubts have been raised about the decision because of the missing data. 

A signed guarantee of data

NICE currently requires pharma firms to produce a statement declaring that all relevant material has been disclosed, signed by the firm’s UK medical director.

But NICE told the NAO: “There is no obligation on the UK medical director to confirm with other offices of the manufacturer that the submission was complete,” meaning there could be hidden or unpublished data that the Institute hasn’t seen.

“A key concern was that, without full clinical trial information, public money could be spent on ineffective medicines,” the NAO says in its report.

To combat this, the report says that NICE should also require pharma to give assurances that they have confirmed, at a global level, that the evidence submitted is complete.

This would give it powers similar to those for its German counterpart IQWiG, which since 2011 has been backed by a legal obligation on pharma to submit a complete list of sponsored clinical trials and all clinical study reports.

An incomplete submission by the manufacturers automatically leads to a negative outcome of the IQWIG assessment, and the NAO would like to see something similar in the UK.

A spokesperson for the Department of Health told Phamafocus it would be ‘considering the points’ made by the NAO, but would not confirm it was specifically looking into expanding NICE’s remit for this purpose. NICE said it would not comment on the recommendations.

The NAO’s findings were sent to the House of Commons Committee of Public Accounts, with its chair, the Labour MP Margaret Hodge, saying: “It is important that NICE and the MHRA assure themselves that they have all clinical trials information”.

This is not only for the public purse, but for public safety, she said, adding that the Department of Health should ‘carefully examine’ how it stockpiles medicines in the future.

Ben Adams

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