The National Institute for Health Research (NIHR) Clinical Research Network, which provides more than £284m a year to support the delivery of clinical research studies in the NHS, has reconfigured and will be operating in a new streamlined structure from April 1st, 2014.
Until this point, the Network has comprised 102 overlapping local networks, each supporting clinical research studies in different therapy areas or parts of the service. From April 2014, this has been rationalized into 15 local Clinical Research Networks across England, which will deliver studies across all therapy areas.
The geographical boundaries of the Networks correlate with those of the Academic Health Science Networks, although the remits of the two organisations remain separate.
Dr Jonathan Sheffield, chief executive of the NIHR Clinical Research Network, explained: “The ability to conduct clinical research is hugely important to the future of the NHS because it is the way we gather evidence to improve the quality of care for patients. Over the last year we have seen significant changes in both the NHS environment, and in the nature of research studies. It was important for the Network to evolve, so we can continue to provide the flexible infrastructure the research community needs to conduct clinical studies efficiently in the NHS.”
The HRA welcomes the announcement of funding for plans for HRA Assessment and Approval. This funding means that the HRA will be able to reduce duplication and bureaucracy by incorporating assessments by NHS staff alongside the independent Research Ethics Committee opinion, which will result in one application, one assessment and one approval for research in the NHS in England.
These proposals will build on recent improvements in timelines for approvals, will radically simplify the regulation of research and will remove complexity for researchers and industry.
The HRA will now streamline this complex process, with the HRA’s Approval addressing practical, legal and ethical aspects of the study. This will allow local research teams to work with their NHS trust to set up and deliver the study.
The NIHR Clinical Research Network has announced that it reached a milestone in study set up achievements by recruiting 25 first global patients in commercial studies in the 2013/14 financial year.
The 25th study to make this highly sought after achievement was at Manchester Royal Eye Hospital, a site of the Central Manchester University Hospitals NHS Foundation Trust. It aims to build on existing safety and effectiveness data for ocriplasmin, a treatment for some people with the rare eye condition, vitreomacular traction.
Recruiting a first global patient is a key performance indicator for the life-sciences industry in clinical research delivery as it shows the Network can support the rapid set-up of studies.
Since the Network started to record first global patients, it has achieved 42 in total. But it is during the past financial year that it has seen a rapid upturn in the number of studies to make the achievement. This is down to the reduction of study set-up times.
The UK House of Commons Science and Technology Committee has described the current lack of transparency of many clinical trials as “unacceptable”, adding that it has not been impressed with Government efforts to tackle the problem to date. The committee has taken written and oral evidence over the past 9 months, and has recently published its report.
Committee Chair Andrew Miller MP said: “We consider that all trials conducted on NHS treatments—and all other trials receiving public funding—should be prospectively registered and their results published in a scientific journal. While the focus should be on implementing this change for future trials, the Government must also do what it can to ensure that historic trials are registered and published, particularly where they have been publically funded.” The Committee also asked the Government to take steps to facilitate greater sharing of the raw data generated during a trial.
The Report also drew attention to the recent fall in the number of trials taking place in the UK, stating that the UK was a “particularly challenging” place in which to conduct a trial. It found that the need for multiple governance approvals from participating NHS organisations remained the biggest barrier to setting up a UK trial, but that lack of public awareness was also a key issue.
The Report called on the Government to take its recommendations into account in ongoing discussions regarding the revision of European clinical trials legislation and in its response to the European Medicines Agency’s consultation on the release of clinical trial data, which closes at the end of this month.
The Department of Health, through the National Institute for Health Research (NIHR) has announced the 15 NHS Trusts/Foundation Trusts that will host the local branches of the NIHR Clinical Research Network from April 2014.
The NIHR Local Clinical Research Networks will distribute £280 million of NIHR funding per year to hospitals and surgeries across England to, pay for research nurses, scans, x-rays and other costs associated with carrying out clinical research in the NHS. The Networks will help to increase the opportunities for patients to take part in clinical research, and will be responsible for making sure that studies are carried out efficiently. They will also support the Government’s Strategy for UK Life Sciences by improving the environment for life-sciences research in the NHS.
Last year, more than 630,000 patients took part in clinical research studies supported by the NIHR Clinical Research Network.
A new report by the National Institute for Health Research Clinical Research Network shows that more than 630,000 NHS patients in England took part in clinical research studies last year – the highest level since the Network’s figures began.
Of particular interest to commercial sponsors, the Network’s new Annual Statistics document, which covers the period April 2012 to March 2013, reported:
- A 17% increase in the number of new commercial contract research studies receiving support from the Network, taking the number of studies supported to 455
- A 19% increase in the number of patients engaged in commercial contract studies, with 20,500 recruited across the year. This continues the upward trend of the last two years.
- A 1% increase in the proportion NHS Trusts in England conducting commercial contract clinical research to 63%
In addition, trend data has revealed that:
- The number of commercial contract studies delivering to 100% time and target has doubled since 2010
- With Network support, it now takes just 61 days (median figure) to gain NHS permission to conduct a commercial contract study across ALL sites involved in the study
- The Network recruited the first global patient into 11 studies in the period September 2012 – March 2013.
Commenting on the increase in patient participation in clinical research, the Chief Medical Officer, Professor Dame Sally C Davies, said: “I am very pleased that NHS Trusts are embracing the research agenda, and that yet again we have seen the level of patient participation in clinical research studies increase. This shows that the infrastructure the government has put in place for clinical research delivery is working effectively and, most importantly, generating valuable opportunities for patients to take part in studies.”
Here is an interview I recorded with Sarah Rickard, at the end of this year’s NHS R&D Forum annual conference.
We reflect on two days of lively and positive discussion on how to manage clinical trials within the NHS, and some of the key themes that were brought out through the conference.