The pharmaceutical industry in England and the UK is responding positively to efforts by the National Institute for Health Research Clinical Research Network (NIHR CRN) to facilitate the set-up, start-up, management and delivery of clinical trials in the National Health Service, the Network says.
Not only did the number of commercial studies adopted into the NIHR CRN Portfolio increase by 43% year on year to 324 in 2010/11 (the NIHR’s financial year runs from 1 April to 31 March), but these studies made up 58% of all industry-sponsored Phase II-IV trials authorised by the Medicines and Healthcare products Regulatory Agency in the UK over the same period, the NIHR CRN noted.
The new data come from the NIHR Clinical Research Network Industry Metrics report for the first quarter of 2011/12. According to the Network, they show the impact of its collaborative work with the life sciences industry and the extent to which this is now “embedded within the research community”.
Among a number of “mutually beneficial” projects undertaken over the last two years, the NIHR CRN cites its study start-up route map, which gives industry “an overview of who does what and when during Network study set-up”; costing templates for trials conducted in the National Health Service; and a study milestone schedule that enables the Network to performance-manage sites more effectively.
It quotes Adrienne Clarke, oncology clinical team manager at GlaxoSmithKline UK, as saying that a growing number of Network studies are meeting performance targets because “performance management is becoming part of Clinical Research Network culture”.
Study delivery by the NHS has remained something of a bugbear despite the string of initiatives to retain and refresh clinical research in a more amenable UK regulatory landscape.
“Within industry, we routinely performance-manage our studies by engaging with investigators and their teams to identify issues and find solutions,” Clarke observed. “However, when this conversation becomes a collaboration between the Network, NHS and the sponsor, it is more powerful.”
At ground level
The NIHR Clinical Research Network has dedicated Industry Managers working at ground level to resolve study set-up issues.
"More companies are returning to the Network because of positive personal experiences,” said Dr Clare Morgan, industry director for the NIHR Clinical Research Network.
“They know we can help them identify sites, which is of particular relevance to companies new to therapeutic areas; they know they gain access to expert feasibility guidance through our clinical specialty groups; and that we can offer hands-on support for study delivery.”Commercial research is a highly competitive field, Morgan pointed out, and companies operating in the UK are increasingly aware that the NIHR CRN “can help their studies perform more effectively in the NHS”, Morgan added.