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Novartis calls for improvements to UK clinical trial system

Says cost of running studies in the country undermines its attractiveness

Novartis UK

The UK needs to do more if it is going to halt the decline in the number of clinical trials conducted in the country, according to Novartis.

A report commissioned by the pharma company said NHS trusts that overcharge, decentralised site structures and under-incentivised investigators are undermining what should be a competitive European market for clinical trials.

Novartis UK's head of clinical trials Helen Townsend told PMLiVE: “One of the areas that stands out that we could really improve on is the clinical trial cost and the consistency around reasonable clinical trial costs.

“We are seen to be quite expensive and we see that as a bit of a shame.”

She said that lack of compliance with the National Institute of Health Research's (NIHR) standard costing template, which provides a quick and efficient way for trusts to sign up for trials, was a particular problem.

Townsend said about half of all trusts “still insist on trying to negotiate increased set up fees, increased management fees”. These can delay the company's patient recruitment time, driving up costs.

“If overall compliance with the costing template alone could be achieved in the UK, we'd be in a really strong position,” Townsend said.

She acknowledged the NHS has steep cost-saving targets, making it very tempting to increase trial costs, but Townsend points out that industry already invests heavily in the UK, spending the equivalent of £12.1m per day on R&D.

The economic environment for R&D
London-based consultants Europe Economics carried out the study, The Economic Environment for Clinical Research & Development in the UK, on Novartis' behalf.

They found that the number of clinical trial applications submitted to the UK regulator the MHRA fell by around 18 per cent from 1,150 in 2005 to 947 in 2011.

Comparing the UK to Spain, Poland, Italy and Germany the report found the UK had the highest clinical trial costs; on average 70 per cent more than trials conducted in Poland and 30 per cent above those conducted in Germany.

It identified four areas where improvements can be made, starting with cost. More has to be made of the UK's unique position in Europe of having a single model clinical trials agreement and its associated cost template, according to the report.

Novartis also called for the structure of clinical trials system to chang, requesting the government explore the scope for centralising drug trials under a regional hub to create efficiencies in specialisation and patient referral.

The payment structure for clinical trials was identified as another problem area, requiring “a cultural shift in attitudes towards trialling” and a review of funding flows, to ensure that investigators are adequately incentivised for the R&D work undertaken the report says.

Novartis also took issue with government policies, saying that some – like the patent box – had unintended consequences.

The report said consideration should be given to ensuring that the patent box can be used by companies exploiting intellectual property in the UK, not just those companies who register their IP in the UK. R&D tax credits should also be reviewed.

But speaking to PMLiVE, Townsend struck a more conciliatory tone, concluding that the situation is improving and saying the company wants to work with the government, NHS trusts and the NIHR to keep that momentum going.

27th November 2012

From: Research



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