International Clinical Trials Day: 20 May
International Clinical Trials Day is celebrated around the world on or near the 20 May each year, to commemorate the day that James Lind started his famous trial on the deadly disease scurvy. It provides a focal point to raise awareness of the importance of research to health care, and highlights how partnerships between patients and healthcare practitioners are vital to high-quality, relevant research.
Professor Dame Sally Davies, Chief Medical Officer and Chief Scientific Adviser at the Department of Health said: “Clinical Trials are a vital element of the work supported and funded by the National Institute for Health Research (NIHR). Our role is to develop the research evidence to support decision making by professionals, policy makers and patients, make this evidence available, and make it available through publication to encourage its uptake and use.”
The NIHR funds a wide range of programmes and infrastructure initiatives to support this aim.
NIHR Infrastructure provides the support and facilities the NHS need for first-class research that results in high-quality care for patients and the public. Our entire infrastructure supports collaborations with industry. Key facilities include the Clinical Research Network, part of the NIHR which helps to provide the infrastructure that allows high-quality clinical research to take place in the NHS. The network helps researchers to:
- set up clinical studies quickly and effectively,
- support the life-sciences industry to deliver their research programmes,
- provide health professionals with research training; and
- work with patients to ensure their needs are at the very centre of all research activity.
In addition, the Clinical Research Network helps patients, carers and the public get involved in all stages of the research process, either as participants voluntarily taking part in clinical or other research studies or by getting actively involved in the different stages of research and related activities. The network has a range of support information on its Patient and Public Information pages.
NIHR Clinical Trials Unit Support Funding was introduced to strengthen capacity for designing and conducting clinical trials and other evaluation studies. It does this by providing funding to offer additional stability and flexibility, and giving units increased capacity to support applications and projects to NIHR research programmes.
The NIHR Trainees Coordinating Centre (TCC) makes training awards to researchers whose work focuses on people and patient-based applied health research. These include newly announced NIHR Clinical Trials Fellowships designed to support existing NIHR Trainees. The trainees have an interest in, and experience of, working with clinical trials as part of their current training and would benefit from further CTU based training.
Research is commissioned and funded through a range of NIHR programmes. Our main priority is to make sure that funding for research is focused where it is needed. In addition, it is to provide quality outputs and value for money through a transparent and accountable system. Most of these programmes are coordinated and managed by two centres: the NIHR Central Commissioning Facility (CCF) and the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC).
The NIHR Health Technology Assessment (HTA) programme produces independent research information about the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS. These cover a broad range of topics which include:
The Efficacy and Mechanism Evaluation (EME) programme is broadly aimed at supporting 'science driven' studies with an expectation of substantial health gain, and aims to support excellent clinical science with an ultimate view to improving health or patient care. Its remit includes clinical trials and evaluative studies, in patients. It evaluates clinical efficacy of interventions (where proof of concept in humans has already been achieved) which may add significantly to our understanding of biological or behavioural mechanisms, and processes. Funded trials cover a range of innovative topics including:
The EME programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland and NISCHR in Wales and the HSC R&D, Public Health Agency in Northern Ireland
The NIHR Research for Patient Benefit (RfPB) programme is a national, response-mode programme established to generate high quality research for the benefit of users of the NHS in England. It funds regionally-derived applied research projects in health services and social care. Its main purpose is to realise, through evidence, the huge potential for improving, expanding and strengthening the way that healthcare is delivered for patients, the public and the NHS.
An example of a project is a randomised trial comparing delivery of cancer systemic therapy in three different settings: patient’s home, general practice surgery and hospital day unit. Preliminary results from this trial suggest that treatment in the community is safe and does not result in a significant increase in costs. The study suggests that patient preference is to have cancer treatment nearer to home, for example at their GP’s surgery. Another study has results into Erectile dysfunction: a randomised controlled trial of lipid lowering. It suggests that simvastatin, the lipid lowering drug used to control elevated cholesterol, could be effective in improving sexual health related quality of life and reducing cardiovascular risk in men with ED.
NIHR Programme Grants for Applied Research (PGfAR) are prestigious awards of up to £2m over a period of three to five years. It is directed towards leading researchers who can demonstrate an impressive track-record of achievement in applied health research. Each programme funds a series of related projects, which form a coherent theme in an area of priority or need for the NHS. For example, the programme treatment of Anorexia nervosa: Translating experimental neuroscience into clinical practice consists of a several sub-projects using clinical trial and observational methodologies.
The primary aim of this trial is to establish the size of the beneficial effect of a guided self-help intervention to assist carers in supporting the recovery of patients who have been hospitalised for Anorexia Nervosa. Another programme; coercion in mental health, patterns and prevalence of coercion in mental health care and a trial of the effectiveness and costs of Supervised Community Treatment orders, consists of a several sub-projects using clinical trial and observational methodologies. Its aim is to test the hypothesis that Community Treatment Orders (CTOs) reduce the readmissions of patients to hospital. CTOs are a means on supervising people with severe mental disorders in the community following involuntary hospital stays.
The NIHR, as the lead organisation for funding clinical trials, has now taken over responsibility for the Clinical Trials Toolkit. This is a web-based resource providing practical advice and help to researchers in designing and conducting clinical trials. The Toolkit was originally developed for clinical trialists and research and development managers; however, much of the advice is relevant to the wider clinical trials and research environment.
The UK Cochrane Centre (UKCC) is part of the NIHR, providing training and support to Cochrane entities and contributors to The Cochrane Collaboration in the UK, Ireland, and some other countries. It also acts as a knowledge broker for Cochrane reviews and runs a programme of methodology research and audit, establishing a key link between the Collaboration, Cochrane reviews, and the National Health Service.
A series of podcasts has been compiled by The Cochrane Collaboration. This collection of evidence pods includes information on how the mega-trials of the last two decades. It has shown that the recruitment of 20,000 or more patients to a high priority study, such as the NIHR-funded CRASH-2 trial, can have a major impact on the care of millions of other people. It has been prepared in collaboration with the MRC’s Network of Hubs for Trials Methodology Research, highlighting the role of this network in conducting and disseminating research into the conduct of trials.