Rheumatology Advance Access originally published online on April 14, 2008
Rheumatology 2008 47(6):745; doi:10.1093/rheumatology/ken112
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EDITORIALS |
The UK Clinical Research Network—building a world-class infrastructure for clinical research
UK Clinical Research Network, MRC Clinical Trials Unit, London
Correspondence to: J. H. Darbyshire, UKCRN, MRC Clinical Trials Unit, Stephenson House, 2nd Floor, 158–169 North Gower Street, London NW1 2ND, UK. E-mail: JHD{at}ctu.mrc.ac.uk
The recognition by both the academic and commercial sectors that clinical research in the UK was under threat led to the development of the UK Clinical Research Collaboration (UKCRC) in 2004. This brought together for the first time funders of clinical research in the UK from the public, charity and private sectors, academic institutions, regulatory bodies and patients and the public. Strengthening the research infrastructure for clinical research was one of the key workstreams of the UKCRC with the goal of building on the UK's unique advantage of the NHS to produce a world-class infrastructure for clinical research.
The establishment of the National Cancer Research Network (NCRN) in 2000 demonstrated that providing new resources to strengthen the research workforce led to a more than doubling of recruitment to clinical trials and other well-designed studies in 3 yrs. The provision of new resources to set up research networks in five additional topics, mental health (in 2003), dementia and other neurodegenerative diseases, diabetes, medicines for children and stroke (all in 2005) was the next step and a primary care network followed in 2007. All of these networks were tasked both to establish the infrastructure within the NHS in England to support clinical trials and other well-designed studies and also to oversee a portfolio of high-quality research. Parallel activities were initiated in Northern Ireland, Scotland and Wales.
It was widely acknowledged that there were other important areas of disease and health care need, particularly those such as musculoskeletal, respiratory and cardiovascular diseases that cause major morbidity and/or mortality, which also need to be supported and this was addressed in the new NHS R&D Strategy Best Research for Best Health that was launched in 2006. This included plans for the National Institute of Health Research (NIHR) and for a Comprehensive Clinical Research Network (CCRN) in England to support clinical research in all areas of disease and health care need.
The NIHR CCRN will become the main route for the provision of service support costs in England from 2009 for all areas of clinical research in primary, secondary and tertiary care and in mental health. It will also provide research management support for all those clinical studies (trials and other well-designed studies) that are included in the NIHR portfolio. Eligibility for the portfolio has been defined by the UK Department of Health (DH) (www.ukcrn.org.uk) and all studies funded by an NIHR partner (defined as an organization that funds research that is of clear value to the NHS and takes account of DH priorities and needs in its research strategy, in open national competition and with independent peer review) will be automatically eligible. Studies funded by industry and other potentially eligible funders will need to go through an adoption process but adopted commercially sponsored studies will have high priority.
The NIHR CCRN will not have the remit to drive and oversee the portfolio of research in specific areas like the six topic-specific and the primary care networks. However, the UKCRN Coordinating Centre is committed to work with the academic and clinical communities and their professional bodies and with research funders, particularly medical research charities, patients and the public to drive research portfolios in other areas such as musculoskeletal disease.
The musculoskeletal community has taken a lead in working with UKCRN to explore how to ensure that its research priorities are supported by the NIHR CCRN, and in this issue, Silman describes how the plans are developing [1]. By developing its strategy in line with the requirements defined by DH, the Arthritis Research Campaign (ARC) is an NIHR partner and so all of the clinical trials which it funds will have automatic access to the NIHR research infrastructure, service support costs and research management support through NIHR CCRN. The process of providing support is in transition but by 2009 it is anticipated that the NIHR CCRN will be fully supporting clinical research in the NIHR portfolio. As a consequence these resources will permit a substantial increase in the number and scope of studies that a funder such as ARC can support.
In parallel with these activities in clinical research infrastructure, the UKCRN has a number of other workstreams to support clinical research which include research governance with the aim of ‘busting bureaucracy’, in response to a frequently heard pleas from the clinical including the rheumatological community. In addition, these activities include working with clinical trial units to provide the expertise in design, conduct and analysis needed for high-quality research, experimental medicine to ensure links with clinical research, training and education to develop a skilled workforce, patient and public involvement to facilitate input at every stage of the research process, industry liaison to work closely to ensure their needs are addressed and information systems linked closely with NIHR to underpin all of the activities. Perhaps the most important workstream in these exciting but challenging times is communication. The changes which UKCRN has already made by implementing the Topic-specific and Primary Care Research Networks and now extending to the NIHR CCRN are both major and rapid—the transition is undoubtedly challenging but the goal is a world-class infrastructure to support clinical research. It is an exciting time for the musculoskeletal community—not only do you have a committed research charity funder but working closely with UKCRN will enable you to both define and access the support that is needed to rapidly take forward both commercial and non-commercial research. The musculoskeletal community needs to take advantage of these opportunities to develop and deliver a high-quality portfolio of research with the ultimate goal of improving patient care.
Disclosure statement: The author has declared no conflicts of interest.
References
- Silman A. A new paradigm for musculoskeletal clinical trials in the UK: the Arthritis Research Campaign (ARC) clinical studies groups initiative. In: Rheumatology (2008) 47:777–9.
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