There are encouraging signs that the pharmaceutical industry is prepared to route trials through the new networks set up under the UK Clinical Research Collaboration (UKCRC).
To date, a total of 34 industry-sponsored trials have been adopted by the topic-specific networks for Cancer, Mental Health, Diabetes, Medicines for Children, Stroke and Dementia/Neurodegenerative Diseases (DeNDRoN). Another 54 industry trials are at the feasibility stage, Dr Richard Tiner, medical director of the Association of the British Pharmaceutical Industry (ABPI), told a recent conference organised by the Manchester Medicines Network.
One of the founding principles of the UK Clinical Research Network (UKCRN) was effective collaboration with the pharmaceutical, biotechnology and medical device industries. There is industry involvement at all levels of the initiative, from the strategic objectives of the CRN’s Industry Road Map Group – including standardisation of costing methods, trial agreements and NHS research and development approvals – through to the industry leads appointed by each of the topic-specific networks.
The aim is to steer industry and the NHS towards mutually beneficial partnerships while resolving issues that have soured relations in the past, such as trial costs, set-up and delivery times or adherence to patient recruitment targets. That should help to stem the drift of commercial clinical trials to lower-cost markets in Eastern Europe, China or India.
Cancer research in the lead
Unsurprisingly, Dr Tiner’s data showed the Cancer Research Network in the lead with 13 industry studies adopted and 18 at the feasibility stage. The cancer network was established well ahead of the UKCRN in 2001 and has served as a model for other research networks. However, Diabetes is making rapid progress with 10 industry trials adopted, followed by DeNDRoN (four), Stroke and Children Medicines (three apiece) and Mental Health (just one, but 10 undergoing feasibility assessment).
The bulk of the adopted studies (22) are Phase III trials, although sample sizes are generally quite small. In total, just five of the industry-sponsored studies have sample sizes of 100-500 patients while three have more than 500. Dr Tiner said industry was testing the system out and cohort sizes could expand significantly if things ran smoothly. He also expected a single, centralised R&D sign-off for NHS trials to be available within the next six months, which would make a “huge difference” to industry.
Less gratifying was the attention paid to the costing guidance on commercial clinical trials published in January 2005 by a working group of the NHS R&D Forum, industry and the Institute of Clinical Research. While 67% of ABPI member companies were now using this guidance, it had not generally been taken up by NHS trusts, Dr Tiner noted. Meanwhile, overheads for clinical trials in the NHS had risen by 40% overall in 2006. In one instance, a trial site had doubled its overheads for a respiratory study.
Start up times a sore point
Start-up times for NHS trials were another sore point. The median time from first submission to first patient/visit was still 170.1 days, Dr Tiner said. He hoped to see a marked improvement in these figures through centralisation of R&D sign-offs and the revised model Clinical Trials Agreement endorsed last October by industry, the Department of Health and other interested parties such as the NHS Confederation and the Council of Heads of Medical Schools.
Recruitment times, though, had shown signs of improvement. Last year, average recruitment within set timelines by UK sites in international studies was 91.9% against 75% in 2005, Dr Tiner reported. Not that recruitment was by any means a given: in all, an average 23% of UK clinical trial sites were going through the set-up process and simply failing to recruit.