Clinicians rely on the latest research evidence to support their treatment decisions and ensure patients receive the best evidence-based care. Research is a fundamental part of the NHS, and all organisations involved in delivering care are obliged, through the NHS constitution, to facilitate research within their organisations.
The National Institute for Health Research (NIHR), through its Clinical Research Network (CRN), provides some of the resources and infrastructure to enable this to happen. Read on to understand how the CRN works and how to access support for your research study. You will also learn about new initiatives that the NIHR CRN is undertaking in partnership with the Society for Endocrinology, to develop and promote research in endocrinology, metabolic disease and obesity.
WHAT SUPPORT DOES THE CRN OFFER RESEARCHERS?
The CRN’s Study Support Service helps to plan, set up and deliver research in the NHS. In the early stages, the Service might advise researchers about study feasibility and attribution of research costs, or help identify appropriate research sites. Once a study is funded and assessed as eligible for CRN support, local CRN teams may work closely with study teams in a number of ways, to ensure that recruitment targets are met within the planned time frame. Examples include provision of CRN-employed research nurses/health professionals to aid recruitment of subjects, as well as proactive performance-monitoring activities such as troubleshooting of barriers to recruitment, and sharing of good practice. For more information, visit the NIHR website.
WHAT TYPES OF STUDIES ARE SUPPORTED?
To be eligible for support, the research must contribute to generalisable new knowledge which is of clear value to the NHS and take into account the NHS’s needs and realities. In practice, this means that there must be clearly defined research questions which will be tested with rigorous methodology. Audits, biobanks and local service evaluations and needs assessments would generally be excluded.
If the research is not sponsored by industry, the funding of the study must have been awarded in open competition across England and have been subject to high quality peer review. In the case of investigator-initiated, commercially funded studies (i.e. funded but not sponsored by industry), the funder is required to confirm that the funding opportunity was open to all qualified researchers in England, even if there was no formal structured competition leading to its award, and the sponsor is required to confirm that appropriate peer review has taken place.
Studies sponsored by industry will not be subject to the open competition and peer review requirements, but will be reviewed for feasibility prior to receiving CRN support, although it is expected that the support costs for commercial research will be fully recovered from industry. Note that all research studies must be in receipt of funding to meet all research costs before they can be considered for CRN support.
‘Many endocrine conditions are under-represented in UK clinical research. The CRN is working together with the Society for Endocrinology’s own Endocrine Networks to encourage researchers to collaborate.’
The CRN’s portfolio of ‘Metabolic & Endocrine’ studies usually includes about 80 open studies at any one time. In 2016–2017, over 4,400 patients were recruited into clinical research studies in the portfolio.
Approximately one-third of the portfolio is made up of studies on rare inherited metabolic disorders, such as glycogen storage diseases and alkaptonuria. These are generally run by specialist centres with an interest in these disorders. Between one-quarter and one-third are on obesity. The remainder are studies into what would be considered general and specialist endocrinology, such as thyroid disease, Cushing’s syndrome and polycystic ovary syndrome. About a quarter of all studies are commercially funded.
EXPANDING UK ENDOCRINE AND METABOLIC RESEARCH
Compared with some other specialities (such as cancer, cardiovascular disease and diabetes), endocrine research makes up a smaller portfolio, with many studies in rare diseases. (These are defined by the Medical Research Council (MRC) as conditions that affect fewer than 5 in 10,000 people.)
It therefore makes sense for studies to be collaborative and involve as many sites as practical to achieve the study aims. Some examples of highly successful observational studies in endocrinology that have involved many sites include the adult growth hormone database, the inherited disorders of sexual development study (I-DSD), and the genetics of endocrine tumours (the AIP study).
Improvement in the proportion of ‘Metabolic & Endocrine’ studies from the CRN’s portfolio recruiting to time and target (RTT).
Despite these successes, and an increase in the proportion of studies recruiting to time and target (see Figure), it is recognised that many endocrine conditions are under-represented in UK clinical research. Consequently, the CRN is working together with the Society for Endocrinology’s own Endocrine Networks to encourage researchers to collaborate in writing applications for clinical research studies for NIHR and other major funders.
There will be an opportunity for the Endocrine Networks to meet during the forthcoming Society for Endocrinology BES conference in Harrogate in November. I encourage all clinicians who are interested in being involved in research (there is no requirement to be currently research-active) to come along and help generate and discuss ideas for new research projects in your own area of interest (see Table).
A networking event with key industry partners is also anticipated. We hope this could encourage new interactions between researchers and industry, so that pharmaceutical and device companies can consider opportunities to work with UK-based endocrinologists. It will also provide an opportunity for researchers to discuss their own ideas and the needs of their patients with industry partners.
John P H Wilding
National Specialty Lead for Metabolic and Endocrine Disorders NIHR Clinical Research Network
If you would like to get involved or if you have any ideas for new research studies that would benefit from this collaborative initiative, please contact email@example.com.