Increasing research capacity and capability – How can national infrastructure help?
Correspondence: John S. McGrath, Department of Urology, Exeter Surgical Health Services Research Unit, Royal Devon and Exeter NHS Trust, Exeter, Exeter EX8 5AB, UK.
Comprehensive Clinical Research Network
Comprehensive Local Research Network
National Institute for Health Research
Over the last 5 years there has been a rapid and radical change in the way clinical research in the UK is funded and supported within the NHS. In 2005, the National Institute for Health Research (NIHR) was established as part of the Government's new health research strategy entitled ‘Best Research for Best Health’ (Department of Health, 2006). The remit of the Institute is to establish the NHS and Universities as an integrated world-class establishment for the delivery of high quality clinical research. It was borne out of the recognition that the preceding years had been characterised by under-performance relative to other countries, despite the fact that the NHS should in fact be an ideal environment for health research.
The NIHR's budget has grown to £1 billion (≈1% of NHS funding), which includes enhanced funding for response mode, and commissioned funding streams, e.g. the Health Technology Assessment programme. NIHR research grants and support for research centres (e.g. the Biomedical Research Centres) span the whole of the research and development pathway from invention, through evaluation and adoption to diffusion (http://www.nihr.ac.uk/Pages/default.aspx).
A major component of the NIHR is infrastructure support embedded in the NHS and governance systems intended to streamline and facilitate the delivery of research. NIHR Clinical Research Networks have been established in six topic areas (e.g. cancer, mental health and stroke), a Primary Care Research Network and, in 2007, the Comprehensive Clinical Research Network (CCRN) was established, which supports research in 24 specialties, each coordinated by a National Specialty. Surgery, Renal and Reproductive Medicine and Childbirth are three of these groups, which cover urogenital medicine as a specialty, thereby encompassing urological research. The role of the CCRN is to:
- Ensure patients and healthcare professionals from all parts of the country are able to participate in and benefit from clinical research;
- Integrate health research and patient care;
- Improve the quality, speed and co-ordination of clinical research;
- Increase recruitment to studies in the NIHR portfolio;
- Increase collaboration with industry partners and ensure that the NHS can meet the health research needs of industry.
The CCRN is comprised of 25 geographically designated Comprehensive Local Research Networks (CLRNs), which cover the whole of England (the Devolved Nations have similar arrangements in place to support clinical research). Each CLRN provides local support for studies that are on the national NIHR Portfolio and deliver a streamlined national system for research and development approvals (CSP, the Coordinated System for gaining NHS Permissions). In this fashion, much of the bureaucracy associated with opening studies at local sites can be removed from the local researcher. In addition, local researchers can use nursing and administrative support from the CLRN to assist in identification, recruitment, consent and monitoring of patients eligible for trial entry. Funding for consultant time, as well as funding for extra NHS costs linked to a study (e.g. radiology), can also be provided. Most of the funding to CLRNs is ‘activity-based’ and therefore the greater the recruitment level, the larger proportion of the CCRN budget the CLRN receives.
Each local network (CLRN and Devolved Nation) can nominate Local Specialty Group Leads who sit on the National Specialty Group, thereby ensuring geographical coverage for the given specialty at a national level. Each National Specialty Group meets several times a year and actively manage their research portfolios through regular progress review, identification of the barriers to recruitment and actions to break these down. They also make decisions on whether or not to ‘adopt’ studies onto the National Clinical Research Network Portfolio, as well as supporting feasibility assessments and identifying sites that would be suitable for specific studies.
Studies that are funded by an NIHR partner organisation (which includes Research Councils, Government Departments and a large number of charities) are automatically entered onto the database whilst others, e.g. studies funded by overseas charities and governments and industry, need to go through an adoption process. More information about portfolio eligibility can be found at: http://www.crncc.nihr.ac.uk/about_us/processes/portfolio
All studies on the National Portfolio upload monthly recruitment statistics using an on-line system and this information is compared with predicted figures to allow early detection of studies that are falling behind target. CLRNs and National Specialty Groups can then work with the investigators to identify particular support requirements or provide advice about opening additional recruitment sites or directing local resources to unblock local barriers.
Success of the National Model
The NIHR Clinical Research Network is the largest integrated research delivery organisation in the world. It has already achieved its objective to double the number of participants involved in clinical research studies with 500 000 now recruited each year.
The focus of the Network is now to ensure that studies recruit successfully within the NHS within their specified recruitment windows, thereby ensuring that patients derive the most benefit from the research carried out in the NHS and new treatments are identified and introduced in a timely way. Recruitment into surgery studies poses particular challenges. Trials are often complex in their design and clinical equipoise is a constant challenge. For these reasons surgical trials have often struggled to complete successfully with sufficient patients to provide a statistically robust result. However, with the support of the NIHR through its networks and National Specialty Groups, this is improving. In the last 15 months, the percentage of open surgical studies that are meeting their recruitment rates has increased from 27% to 40%. Clearly there is room for improvement and the focus on ensuring rapid study set-up times along with the continuation of targeted support to studies should further improve recruitment rates.
Since 2006, the NIHR has supported several major surgical research projects, worth > £40 million in total. Nevertheless, the number of surgical research studies is low compared with other specialties and in February 2012 the NIHR issued a call for research on the evaluation of technology-driven implanted or implantable medical devices, surgical procedures or surgical services. Six of the NIHR managed research programmes participated and this has stimulated a considerable number of applications for new research projects that are now being reviewed through the NIHR's usual peer review processes. This targeted call should extend the current portfolio of surgical research studies and will offer more opportunities for healthcare professionals and patients to participate in successful urological research studies across the UK.
Further information about how to get involved in urological research can be found at: http://www.crncc.nihr.ac.uk/about_us/ccrn/specialty
Conflict of Interest