Guidance

Experimental medicine and clinical trials

Updated 1 December 2021

Introduction to experimental medicine and clinical trials

The UK offers a fast, cost-effective and high quality location for experimental medicine and clinical research.

This is supported by:

• translational research expertise
• unrivalled access to data
• leading research facilities

Clinical Research Networks are embedded in the National Health Service (NHS) supporting the delivery of multicentre clinical studies, with more than 3 million patients recruited over the last 6 years.

Numerous UK organisations give support, advice or useful information for each development stage of experimental medicine and clinical trials.

Discovery and deep research development stage: UK support organisations

Association of Medical Research Charities (AMRC)

AMRC is the national membership organisation of leading medical and health research charities. It supports over one third of all publicly-funded medical research in the UK.

Cancer Research UK Commercial Partnerships

This arm of Cancer Research UK develops and commercialises exciting new discoveries in cancer research. It is the meeting point between academia and industry and translates promising research into commercial propositions.

Clinical Practice Research Datalink (CPRD)

CPRD is a governmental, not-for-profit research service, jointly funded by the NHS National Institute for Health Research (NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA) , a part of the Department of Health and Social Care (DHRC).

It has been providing anonymised primary care records for public health research for 30 years. It enables observational studies, clinical trial feasibility and protocol optimisation, and post-market surveillance.

The Farr Institute of Health Informatics Research

The Farr Institute is a UK-wide research collaboration involving 21 academic institutions and health partners in England, Scotland, and Wales. Publicly funded by a consortium of 10 organisations led by the Medical Research Council (MRC), it’s committed to delivering high-quality, cutting edge research using ‘big data’ to advance the health and care of patients and the public.

Medical Research Council (MRC)

The MRC improves human health through world-class medical research. It funds research across the biomedical spectrum and its research has resulted in life-changing discoveries for over 100 years. Its work ranges from laboratory research, for example on genes and molecules, right through to clinical trials and population studies.

MRC’s science is split into 6 broad areas of research which includes:

• infections and immunity
• molecular and cellular medicine
• neurosciences and mental health
• population and systems medicine
• global health
• translational research

Its research is carried out in universities, hospitals and a network of dedicated establishments across the UK and Africa.

National Institute for Health Research (NIHR)

The NIHR is funded through DHSC. It builds capacity and leadership in the research workforce, and attracts investment into the UK by supporting partnerships with life science companies, including small and medium enterprises, and charities.

NIHR Clinical Record Interactive Search (NIHR CRIS) system has been developed for use by the NIHR Maudsley Biomedical Research Centre and Dementia Biomedical Research Unit at the South London and Maudsley (SLaM) NHS Foundation Trust. CRIS provides authorised researchers with regulated access to a wide range of pseudonymised information extracted from the SLaM electronic clinical records system.

NIHR Experimental Cancer Medicine Centres (ECMC) funds 14 Experimental Cancer Medicine Centres across England in close partnership with Cancer Research UK.

The centres play a leading role in speeding up the process of cancer drug development and the search for cancer biomarkers – molecules present in blood or tissue - that can:

• be used to diagnose cancer
• predict the aggressiveness of the disease
• show whether a drug will be effective in a specific patient and at what dose

NIHR Health Informatics Collaborative (NIHR HIC) brings together 5 of the country’s leading NHS Trusts with large NIHR Biomedical Research Centres to make NHS clinical data more readily available to researchers, industry and the NHS community.

It focuses on 5 scientific themes which are:

• acute coronary syndromes
• ovarian cancer
• hepatitis
• renal transplantation
• intensive care

UK Biobank

UK Biobank is a unique resource of data and samples linked to medical histories and health records from 500,000 adult participants and is open to bona fide researchers anywhere in the world, including those funded by academia and industry. It’s a major national health resource, and a registered charity in its own right.

Wellcome Trust

The Wellcome Trust funds both basic biomedical research and translational projects.

Wellcome Trust-Wolfson Northern Ireland Clinical Research Facility (NICRF)

The NICRF provides state-of-the-art clinical research facilities focusing on:

• cancer
• nutrition and metabolism
• vision science
• respiratory research

Development and translation development stage: UK support organisations

Edinburgh BioQuarter

Edinburgh BioQuarter brings together academic scientists, clinicians, patients and other health professionals with companies. It utilises world class academic and clinical research facilities, to enable collaboration and accelerate the development of new drugs, diagnostic tools and medical devices, to diagnose and treat diseases.

Health and Care Research Wales

Health and Care Research Wales:

• provides an infrastructure to support and increase capacity in R&D
• runs a range of responsive funding schemes
• manages resources to promote, support and deliver research in health and social care
• facilitates the successful delivery of commercial research in the NHS
• promotes Wales as an effective place to do research

Health Science Scotland

Health Sciences Scotland makes it easier for commercial organisations to develop mutually beneficial partnerships with clinical and research expertise across medical universities and their associated NHS Health Boards in Scotland.

National Institute for Health Research (NIHR)

The NIHR is funded through the DHSC. It builds capacity and leadership in the research workforce, and attracts investment into the UK by supporting partnerships with life science companies, including small and medium enterprises, and charities.

NIHR Biomedical Research Centres (BRCs) were formed through partnerships between England’s leading NHS organisations and universities, 20 NIHR Biomedical Research Centres. They conduct translational research to transform scientific breakthroughs into life-saving treatments for patients. Staffed by expert investigators and clinicians, the centres are leaders in translating lab-based discoveries into new cutting edge treatments, technologies, diagnostics and other interventions in clinical settings.

NIHR Biomedical Research Units (BRUs) are based within England’s leading NHS organisations and universities. They undertake translational research in priority areas of high disease burden and clinical need.

The units focus on specific therapeutic areas of disease including:

• musculoskeletal
• gastrointestinal
• respiratory
• cardiovascular
• dementia,
• nutrition
• diet and lifestyle
• deafness and hearing

NIHR BioResource is a panel of thousands of volunteers, both with and without health problems, who are willing to be approached to participate in research studies investigating the links between genes, the environment, health and disease.

NIHR Clinical Research Facilities (NIHR CRFs) are dedicated and purpose built facilities with specialist clinical research and support staff, conducting commercial and non-commercial experimental medicine studies.

NIHR Clinical Research: Network Study Support Service is the research delivery arm of the NHS in England. One of its priorities is to proactively support the life-sciences industry to deliver high quality commercial contract clinical research across all therapeutic areas. Its free-of-charge study support Service helps life-science organisations effectively find investigators and sites, set-up and deliver their studies to time and target.

NIHR Collaborations for Leadership in Applied Health Research and Care (NIHR CLAHRCs) bring together a collaboration of the local providers of NHS services and NHS commissioners, universities, other relevant local organisations and the relevant Academic Health Science Network (AHSN).

CLAHRCs conduct applied health research across the NHS, and translate research findings into improved outcomes for patients. The 13 NIHR CLAHRCs primarily focus on research targeted at chronic disease and public health interventions.

NIHR Dementia Translational Research Collaboration (NIHR D-TRC) was established to pull discoveries from basic science into real benefits for patients. It comprises 4 NIHR Dementia Biomedical Research Units as well as 6 NIHR Biomedical Research Centres with dementia-related research themes. These units and centres are world leaders in dementia translational research, based within top NHS-university partnerships.

NIHR Experimental Cancer Medicine Centres (NIHR ECMCs) play a leading role in speeding up the process of cancer drug development and the search for cancer biomarkers – molecules present in blood or tissue.

These can be used to:

• diagnose cancer
• predict the aggressiveness of the disease
• show whether a drug will be effective in a specific patient and at what dose

The NIHR funds 14 Experimental Cancer Medicine Centres across England in close partnership with Cancer Research UK.

NIHR Office for Clinical Research Infrastructure (NIHR NOCRI) operates in England and enables you to demonstrate the clinical performance of your medical technology at pace. The research infrastructure works with industry to design protocols, providing access to world leading academic and clinical expertise, enabling you to output high quality evidence.

NIHR Patient Safety Translational Research Centres (NIHR PSTRCs) work to pull advances in basic research with potential relevance to patient safety into an applied research setting.

The 2 centres (Imperial and Greater Manchester) bring together a range of research disciplines from the NHS and universities. They undertake research to drive forward improvements in patient safety and safety of NHS services in hospitals and GP surgeries.

This research has the potential to translate into real benefits for patients, such as reducing prescription errors, improving diagnosis of cancer and rare diseases and reducing accidents during surgery.

NIHR Rare Diseases Translational Research Collaboration (NIHR RD-TRCs) increases the volume of in depth pheno-typing and links this to data on genomic abnormalities to provide greater understanding of the mechanisms underlying rare diseases.

NIHR Translational Research Partnerships (NIHR TRPs) bring together the UK’s leading academic and clinical centres for experimental medicine and translational research into a ready-formed partnership of Universities and NHS hospitals.

NHS Research Scotland (NRS)

NRS promotes and supports excellence in clinical and translational research in Scotland for patients to benefit from new and better treatments.

It connects NHS, industry and academia to accelerate the development of new treatments, devices and diagnostics to tackle complex healthcare needs.

NICE Office for Market Access (NICE OMA)

NICE OMA provides expert advice to the life sciences industry – pharmaceuticals, health technologies, diagnostics, and devices.

They advise on:

• NICE processes
• how to work with NICE to achieve your aims
• how NICE links with different parts of the system
• the Early Access to Medicines Scheme (EAMS) and how NICE supports it

NICE Scientific Advice (NICE SA)

NICE SA offers a fee-based consultancy service to developers of:

• medicines (including orphan drugs)
• devices
• diagnostics
• a range of services for different product types

Northern Ireland Clinical Research Network (NICRN)

NICRN assists with processes involved in setting up a study, in particular ethical, regulatory and local research governance approval for clinical trials in Northern Ireland.

Regulatory and health technology assessment development stage: UK support organisations

Integrated Research Application System (IRAS)

IRAS is a UK-wide system that streamlines the process for applying for permissions and approvals to conduct health and social care research. It allows users to enter the information for the relevant permissions and approvals once, instead of having to complete several separate application forms for each review body.

Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA is the UK’s regulatory agency responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Robust and fact-based judgements underpin all the work carried out to ensure that the benefits justify any risks.

MHRA Innovation Office is a single point of access to expert regulatory information, advice and guidance that helps organisations of all backgrounds and sizes develop innovative medicines, medical devices or novel manufacturing processes. They provide expert knowledge, guidance and experience to help develop products and save time and money.

National Institute for Health and Care Excellence (NICE)

NICE publishes guidance in 4 areas including the use of health technologies within the NHS such as the use of the new and existing medicines, treatments and procedures.

NICE SA offers a fee-based consultancy service

Scottish Medicines Consortium (SMC)

The SMC accepts for use those newly licensed medicines that clearly represent good value for money to NHS Scotland. It analyses information supplied by the medicine manufacturer on the health benefits of the medicine and justification of its price.

The consortium is made up of lead clinicians, pharmacists and health economists together with representatives of health boards, the pharmaceutical industry and the public.

Delivery, supply and NHS / patient development stage: UK support organisations

National Health Service (NHS)

The NHS, launched in 1948, is the largest unified healthcare system in the world. It treats almost 1 million patients on a daily basis. It was born out of a long-held ideal that good healthcare should be available to all, regardless of wealth and remains free at the point of use for anyone who is a UK resident. That is currently more than 64.6 million people in the UK.

NHS England sets the priorities and direction of the NHS in England. It shares out more than £100 billion in funds in the commissioning of health care services in England and holds organisations to account for spending this money effectively.

NHS Scotland is the publicly funded healthcare system in Scotland. Health and social care policy and funding are the responsibility of the Health and Social Care Directorates of the Scottish Government. NHS Scotland currently employs approximately 140,000 staff who work across 14 territorial NHS Boards, 7 Special NHS Boards and 1 public health body.

NHS Northern Ireland provides the gateway to Health and Social Care Services in Northern Ireland, and links to the Hospital and Community services provided by the 6 Health Trusts, General Practices, Health and Social Care Board and other HSC Agencies. The Northern Ireland Executive, through its funding of the Health Department is responsible for the funding of the service.

NHS Wales is the official corporate name of the Welsh National Health Service, the publicly funded healthcare system which is the responsibility of the devolved Welsh Government. There are 7 Local Health Boards (LHBs) in Wales and 3 national NHS Trusts. Each LHB is responsible for delivering all NHS healthcare services within a geographical area. Three NHS Trusts, called ‘all-Wales trusts’, operate nationwide agencies and services.

NHS procurement

There are several routes to market for companies interested in supplying goods and services to the NHS.

Read more on Partnering with the NHS to sell goods and services.

NICE Office for Market Access (NICE OMA)

NICE OMA provides expert advice to the life sciences industry.

NIHR Clinical Research Network (NIHR CRN)

NIHR CRN is the research delivery arm of the NHS in England. One of its priorities is to proactively support the life-sciences industry to deliver high quality commercial contract clinical research across all therapeutic areas within the NHS. Their free-of-charge study support service helps life-science organisations effectively find investigators and sites, set-up and deliver studies to time and target.

Scottish Medicines Consortium (SMC)

The SMC accepts for use those newly licensed medicines that clearly represent good value for money to NHS Scotland. SMC analyses information supplied by the medicine manufacturer on the health benefits of the medicine and justification of its price. The consortium is made up of lead clinicians, pharmacists and health economists together with representatives of health boards, the pharmaceutical industry and the public.

Launch global access development stage: UK support organisations

Department for International Trade (DIT)

DIT is the government department that helps UK-based companies succeed globally and assists overseas companies to bring investment to the UK. DIT’s network of government and private-sector specialists, in the UK and in British Embassies and Consulates throughout the world, offers practical advice and free and confidential support.

Life Sciences Organisation (LSO)

The LSO helps UK life science companies do business overseas and encourages foreign life science companies to invest in the UK. It provides support from the earliest stages of research and development through to clinical trials, commercial operations and business partnerships.

Healthcare UK

Healthcare UK is a joint initiative of DHSC, DIT and NHS England.

Healthcare UK helps UK healthcare providers do more business overseas by:

• promoting the UK healthcare sector to overseas markets
• supporting healthcare partnerships between the UK and overseas healthcare providers.

NICE OMA

NICE OMA provides expert advice to the life sciences industry

UK life science membership associations and networking organisations

Find UK life science membership associations and networking organisations who can aid business growth, competitiveness and innovation in the life sciences sector.