UK must improve its recruitment rate in clinical trials, report saysBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8104 (Published 28 November 2012) Cite this as: BMJ 2012;345:e8104
Clinical trials in the United Kingdom cost significantly more than in other European countries, largely because of the need for lengthy negotiations with NHS organisations and poor rates of recruitment, concludes a report produced for the drug company Novartis.1
The number of trial applications in the UK has been falling and could fall further, it warns, unless the system is made more efficient and a “cultural shift” takes place in the NHS.
The report, by Europe Economics, a consultancy that specialises in the application of economics to public policy, says that the average cost of a trial per patient in the UK is now €9758 (£7890; $12 650), higher than in Spain (€7310), Germany (€7232), Italy (€5810), and Poland (€5679). Because of its decentralised system for recruiting patients, the UK does particularly poorly in recruitment, with just 55% of trials reaching a target rate of 90%. Spain and Poland perform much better, with 100% of Spanish trials reaching the target and 77% of those in Poland.
In some UK trials just a handful of patients may be recruited from a particular hospital, yet protracted negotiations may be needed. A costing template exists to set the payments, but hospital trusts often try to charge additional fees, wasting time and raising costs. Because all the fees payable by drug companies go to the trust, with only a small proportion passed on to the investigator’s unit, there is little incentive for individual researchers to become involved.
Many trusts behave as though participation in trials is not part of their core mission and therefore need to be compensated with high charges. They also engage in “free riding,” says the report—that is, while recognising that trials are valuable, they assume that they will get the benefits anyway, as long as some NHS hospital somewhere takes part in the trial. Therefore they see trial approval as “someone else’s job,” the report says.
Traditionally the UK has been a strong centre for clinical trials, which have benefits for patients, the NHS, and the economy. In recent years successive governments, alarmed at statistics showing a decline in clinical trial applications in the UK, have tried hard to produce a favourable environment for pharmaceutical research. The number of applications fell by a third from 1484 in 2004 to 947 in 2011. But the report concludes that more needs to be done, particularly in facilitating the rapid setting up of trials.
One way might be greater centralisation on a “hub and spoke” model in which administration is organised centrally and the “spokes”—local NHS organisations—recruit participants. The aim would be for companies to reach a greater number of patients through fewer sites. One study cited in the report estimates that recruitment might be up to 10 times as fast under this model, reducing the time and cost of a trial.
Sue Webb, UK country president at Novartis, said, “We welcome the developments the government has made so far on the life sciences agenda. We invest over £2m a week in R&D [research and development] and clinical trials in the UK, and it’s an important part of our investment in the UK.
“This is why we’re bringing over 100 clinicians together [on Tuesday 27 November] to debate the issues and the findings of our report on breaking barriers to R&D investment. We want to work with the NHS, government, and academia to make the UK an attractive place for clinical trials, which ultimately helps patients get access to innovative medicines.”
Cite this as: BMJ 2012;345:e8104