Over the last five years, clinical research in England has shown year-on-year growth for both the number of new trials opening and the number of patients recruited, said Matt Cooper, National Institute for Health Research (NIHR) Clinical Research Network (CRN), business development and marketing director.
The NIHR recently reported figures – from April 2018 to March 2019 – which show a record number of patients participating in clinical research. “We have seen the highest participant rates ever this year (over 870,000) and we look to continue this strong level of recruitment over future years,” Cooper told us.
Over the last 12 months, NIHR reported a record number of new studies (2,194), bringing the total number of ongoing studies in England to 6,106, which according to NIHR, is the largest number to date.
Additionally, “every” National Health Service (NHS) trust across the country recruited patients into NIHR studies for the first time since 2015/16, according to the report.
There also is a focus on supporting commercial clinical trials, as the government “recognizes the life sciences industry as a key contributor” to the UK’s commercial community, Cooper said.
Strengthening the UK’s clinical research environment is among the key commitments outlined in the recent Life Sciences Industrial Strategy and Sector Deal.
Additionally, the NIHR CRN has launched national campaigns such as ‘I Am Research’ and ‘Be Part of Research’ to raise awareness about clinical research as part of the NHS Long Term Plan – a key part of which is increasing the number of patients participating in research.
The Long Term Plan
NHS England’s Long Term Plan is a £20.5bn ($25.98bn) investment focused on service delivery in the NHS. Cooper said the objective is to transition the NHS’ delivery model toward preventive care and integration with community service for patients with chronic conditions, prioritizing mental health, maternity, and cancer. It also will include an emphasis on preventing health inequalities.
“As a research network we are flexible enough to respond to changing patterns of health care delivery and so to where research needs to be delivered,” added Cooper. “We are looking to adapt to more research being placed into primary care settings, but also need the life sciences industry to be responsive to change and have protocols that allow primary care as the research site.”
However, change has historically been approached quite conservatively, Cooper noted, adding that the industry also needs to look into other staff types who could work as principal investigators, such as nurse consultants.
As a way to facilitate change, NIHR is employing its Research Targeting Tool – which uses NHS data to map disease prevalence – to help identify areas of disease burden. This map can then be overlaid with a map of where research is currently being delivered in order to “'nudge' study sponsors to open sites where there is the most need and target patient population,” said Cooper.
Addressing Brexit and allaying concerns
Though uncertainty and mixed reports circulate, Cooper said England has continued to see year-on-year increases in the number of commercial clinical trials coming into the UK.
“The life sciences industry still see the UK as a key market in which to conduct clinical trials – we have excellent facilities, key opinion leaders and can produce timely quality data. This will still be the case post-Brexit,” said Cooper.
One specific concern that has been raised about post-Brexit operations is the role of the Qualified Person (QP). Cooper said concerns should be quelled, however, as the Medicines and Healthcare Regulatory Agency (MHRA) has said that any QP done in the EU will only be subject to “a light review” in the UK, rather than a full QP check.
“Trials are global and many countries contribute data to a single study which is then amalgamated and packaged to be presented to the regulator in the country the sponsor wishes to gain marketing approval in,” he added. “The UK will still contribute excellent data pre and post-Brexit. We have not gone into Brexit yet so essentially nothing has changed yet.”