The number of commercial contract studies added to The National Institute for Health Research Clinical Research Network (NIHR CRN) portfolio in England during the first quarter of 2013/14 grew by 27.7% year on year and by 17.3% over the final quarter of 2012/2013, the Network’s latest figures show.
At the same time, the volume of non-commercial studies supported by the Network rose only slightly by 1.4% year on year in Q1 of the new financial year and dipped by 3.1% against the final quarter of 2012/13.
A total of 129 commercial studies were adopted by the Network in April to June 2013, compared with 101 and 110 studies in the first and fourth quarters of 2012/13 respectively.
The corresponding numbers of non-commercial studies were 285 in the latest quarter, 281 in Q1 of 2012/13 and 294 in Q4 of the last financial year.
During the latest quarter, just 56 of all the non-commercial studies added to the NIHR CRN portfolio were adopted, while 229 were automatically eligible for inclusion due to the nature of their funding.
As Lydia Christopher, head of industry operations for the NIHR CRN, noted at a recent National Industry Event held by the Network, typically around 20% of the whole CRN portfolio is commercial studies while another 25% of the portfolio has some commercial component.
The NIHR’s own research programmes may involve “hard-to-reach” areas of limited commercial interest, pointed out Dr Jonathan Sheffield, chief executive of the NIHR Clinical Research Network, at the same meeting,
“Our responsibility is to make sure we cover the whole of the National Health Service”, so there is a “pragmatic balance”, Sheffield commented.
On the other hand, he added, in the current economic climate there is “more opportunity to conduct research from a commercial point of view than ever before”, particularly with medical research charities seeing a drop in income.
The Network wants to ensure it can “fill that gap” with studies from global pharmaceutical and biotechnology companies. Moreover, medical charities are increasingly building research relationships with industry.
High Level Objectives
One of the NIHR CRN’s High Level Objectives is to increase the number of commercial contract studies on the Network portfolio as a proportion of total Clinical Trial Application approvals by the Medicines and Healthcare products Regulatory Agency (MHRA) for Phase II-IV studies.
The target for 2013/14 is 60%, and in the first quarter of 2013/14 the CRN supported 67% of new studies approved by the MHRA during the same period.
This achievement was “all the more impressive” given that the number of studies included in the metric has risen dramatically over the last 12 months (69 in Q1 2012/13, 96 in Q1 2013/14), the Network said.
As Christopher observed at the National Industry Event in London, 99% of NHS organisations are now research-active through NIHR CRN support, while 69% of these organisations are delivering commercial contract studies.
Among other encouraging performance metrics, 4,900 patients were recruited into commercial NIHR CRN portfolio studies during the first quarter of 2013/14, compared with 20,500 patients for the whole of 2012/13 (this latter figure included 30 global first patients).
Study set-up is also showing marked signs of improvement. In Q1 of 2013/14, the median number of calendar days taken to obtain NHS permission across all sites for commercial contract studies in the NIHR CRN portfolio was 38 days, against 55 days for the whole of 2012/13.
When tracking was first introduced in 2010/11, this figure stood at an average 117 days, Christopher noted.
Time and target
The proportion of NIHR CRN commercial contract studies recruiting patients to time and target rose to 63% in the first quarter of 2013/14, a figure that has more than doubled in the last two years.
The Network has set a target of 80% for this performance metric in the full financial year to March 2014.