Here is a list of Frequently Asked Questions. If you can't find the information you require, please contact NOCRI using the Contact Us link at the bottom of the page.
What is Experimental Medicine?
What is a Clinical Research Facility?
What is an Experimental Cancer Medicine Centre?
What is an MRC Translational Medicine Centre?
What is an NIHR Biomedical Research Centre?
What is an NIHR Biomedical Research Unit?
What is Commercially-Sponsored Contract Research?
What is Commercial Collaborative Research
Are there any Agreements or Contracts to support Collaborative Research?
What is an Epidemiology Study?
What is an Observational Study?
What is a Phase 0 or Microdosing Study?
What is a Phase I Study?
What is a Phase II Study?
What is a Phase III Study?
What is a Phase IV Study?
What is meant by “Specialist Paediatric Facilities”?
Who do I contact for more information?
How do I get my facility or centre listed on the site?
Is my facility or centre eligible for inclusion on the site?
What is the application process for inclusion on the website?
What are the terms of inclusion on the site?
Who is responsible for updating the information on this site?
Who are UKCRC?
Who are NOCRI?
What is Experimental Medicine?
Experimental medicine is an investigation in humans to identify the cause of disease and to test the validity and importance of new discoveries and treatments. The effective translation of results from experimental medicine studies into later phase clinical research is an important outcome of experimental medicine, as is the generation of new hypotheses to be explored in the laboratory.
What is a Clinical Research Facility?
Clinical Research Facilities (CRFs) provide a purpose-built environment for patient-centred research, where clinical researchers are able to make use of cutting-edge clinical facilities, technologies and expertise and have access to patients. They provide an environment where collaborations between basic and clinical scientists help to ensure that advances in biomedical research feed through into improvements in healthcare. CRFs support Principal Investigators conducting both academic and commercial research.
Whilst CRFs vary due to local need, all will include the following:
- Outpatient and Inpatient facilities
- Support for high intensity studies which includes overnight stays
- Highly trained dedicated research personnel
- Specialist equipment and laboratories to conduct a variety of studies
- Support with documentation
- Studies conducted to GCP/Research Governance Framework
Additionally some CRFs may be able to provide additional support, subject to funding and availability. Examples of such support include:
- Recruitment services
- Medical cover for studies
- Protocol writing
More information about the CRF initiative can be found on the UK CRF Network website: www.ukcrfnetwork.co.uk
What is an Experimental Cancer Medicine Centre?
An Experimental Cancer Medicine Centre (ECMC) is a translational research centre with both laboratory and clinical facilities and expertise. The resources available in an ECMC allow the safe, rapid and rational evaluation of new cancer treatments, and the development and application of novel biomarkers to facilitate late stage clinical trials and the evolution of personalized medicine.
A network of ECMCs has been developed across the UK as joint initiative between Cancer Research UK and the Health Departments in England, Scotland, Wales and Northern Ireland.
The support provided by ECMC funding is used in each Centre to underpin translational research strengths at each location. Particular strengths vary in each Centre; however, generic themes supported by ECMC funding include early clinical trials of novel therapies - small molecule, immunotherapies and other complex biological therapies - and the development of novel biomarkers - diagnostic, prognostic, predictive, pharmacological and response surrogates.
More information about the ECMC initiative can be found on the ECMC Network website: www.ecmcnetwork.org.uk
What is an MRC Translational Medicine Centre?
A major challenge in medical research is finding ways of translating research findings into practice. As part of its plans for tackling these problems, the Medical Research Council (MRC) issued a call for proposals to create research centres aimed at translating scientific discoveries into new drugs, therapies, diagnostic tools or methods of prevention; or using clinical knowledge to inform fundamental research priorities. The MRC selected six proposals for funding. The MRC Translational Medicine Centres will focus on transplant medicine, obesity, neuromuscular diseases, genomics and global health, outbreak analysis and modelling and the molecular causes and indicators of disease.
More information about the MRC Institutes, Units and Centres can be found on the MRC website: www.mrc.ac.uk
What is an NIHR Biomedical Research Centre?
The NIHR Biomedical Research Centres are leaders in scientific translation across a wide range of disease and therapeutic areas. The Centres are based within England's leading NHS and University partnerships and focus on driving forward innovation and translational research in biomedicine. They provide a direct route to work with this country’s leading investigators and clinicians with the expertise to translate fundamental biomedical research into new and improved therapeutic approaches.
Centres have a comprehensive remit, working across a range of disease and therapeutic areas. A further seven centres work in individual specialist areas, including ageing; cancer; genetics and developmental medicine; mental health; microbial diseases; paediatrics and child health; and ophthalmology.
More information about the NIHR Clinical Research Infrastructure can be found on the NOCRI website: www.nihr.ac.uk/NOCRI
What is an NIHR Biomedical Research Unit?
NIHR Biomedical Research Units bring together some of England's leading health researchers and clinicians to carry out translational clinical research in a number of areas of high disease burden and unmet clinical need. These include cardiovascular disease; deafness and hearing problems; gastrointestinal disease; musculoskeletal disease; nutrition, diet and lifestyle, respiratory disease; infection; and pancreatic disease.
More information about the NIHR Clinical Research Infrastructure can be found on the NOCRI website: www.nihr.ac.uk/NOCRI
What is Commercially-Sponsored Contract Research?
A commercially-sponsored contract research study is one where a company has developed a protocol and is approaching one or more investigators to collect data to support the study. All research costs should be covered by the company who would normally be the sponsor.
What is Commercial Collaborative Research
A commercial collaborative research study is one where a company has approached an investigator or vice versa with an idea for a study and the protocol is developed in collaboration. This definition would also apply to a study where the local investigator has developed the protocol and has approached a commercial company to provide funding. A collaborative research study would typically require sharing of risk (e.g. funding, IP).
Are there any Agreements or Contracts to support Collaborative Research?
A model Industry Collaborative Research Agreement (mICRA) has been developed to streamline and support the contracting process for research partnerships involving the pharmaceutical and biotechnology industries, universities and NHS organisations.
The mICRA is designed to support clinical research collaborations involving the pharmaceutical and biotechnology industries, academia and NHS organisations across the UK.
The model Agreement is supported by a comprehensive Guidance Document which sets out its background and aims and details how the Agreement should be used in the development of contracts for specific clinical research collaborations.
A Decision Tree is also available to guide users in identifying when studies are collaborative and whether mICRA is applicable. The Agreement has a choice of options for clauses covering Intellectual Property arrangements and the Decision Tree guides users through this process
For more information about mICRA or to download the agreement and supporting documentation, please visit www.nihr.ac.uk/NOCRI
What is an Epidemiology Study?
Epidemiological studies on human populations deal with the cause, distribution and control of disease. An Epidemiological study is a statistical study on human populations, which attempts to link human health effects to a specified cause. The most common types of epidemiological studies are case-control studies, cohort studies and cross-sectional studies.
What is an Observational Study?
An observational study is a study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given).
What is a Phase 0 or Microdosing Study?
Phase 0, also known as human microdosing, studies are first-in-human trials designed to speed up the development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies.
Phase 0 trials include the administration of single sub-therapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug works in the body).
A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effects.
What is a Phase I Study?
In Phase I trials researchers test an experimental drug or treatment in a small group of healthy volunteers (20 – 100) to evaluate its safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics.
What is a Phase II Study?
In Phase II trials the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety in healthy volunteers and patients.
What is a Phase III Study?
In Phase III trials, the experimental study drug or treatment is given to large groups of patients (100s or 1000s) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and to collect information that will allow the experimental drug or treatment to be used safely. A Phase III trial can provide enough information for a new treatment or procedure to be used as the new ‘standard treatment’.
What is a Phase IV Study?
Phase IV trials are often referred to as post marketing studies as they occur once a drug has been licensed for use. They provide further information on side effects, safety and longer term risks and benefits associated with the treatment.
What is meant by “Specialist Paediatric Facilities”?
To qualify as having specialist paediatric facilities centres should have dedicated children’s facilities (i.e. not used for adult studies) including a waiting or play area, treatment rooms and in patient/ out-patient beds. Specific requirements for paediatric studies encompass babies, children and young adults up to 19 years of age.
Who do I contact for more information?
For more information please use the “Contact Us” tool on the front page of the UK Experimental Medicine Resource Finder site, or contact NOCRI: NOCRI@nihr.ac.uk
How do I get my facility or centre listed on the site?
To apply for your facility to be listed on the UK Experimental Medicine Resource Finder, please use the “Get Listed” tool on the front page of the site.
Is my facility or centre eligible for inclusion on the site?
Applications will be reviewed against the specific key competencies and evaluation criteria outlined below which cover capability, safety and availability. These key competencies have been developed in order to ensure that facilities included on the Experimental Medicine Resource Finder website meet a minimum set of core criteria.
Applications will be reviewed with reference to the following key competencies:
Capability
- Appropriate infrastructure providing a distinct, research dedicated space for doing investigative clinical science
- Provision of analytical techniques and methodologies required to support clinical research
- Appropriate capacity/ scale of operation
- Dedicated specialist facilities (e.g. human performance laboratories), with appropriate accreditations (e.g. GxP), systems and procedures (e.g. equipment validation, SOPs)
- Appropriate leadership and management structures
- A multi-disciplinary, well trained and experienced team
- Systems and processes in place for continuing professional development, including Good Clinical Practice (GCP) and resuscitation training for all relevant staff
- Appropriate reporting structures in place including clearly defined metrics for the evaluation of the facility’s performance
Safety & Quality
- Systems and processes in place to ensure that staff work to appropriate guidelines and standards
- Systems and processes in place to meet appropriate regulations and legislation (e.g. the principles of ICH-GCP, the NHS Research Governance Framework, the Data Protection Act and the UK Regulations that implement the EU Directive for Clinical Trials, GxP)
- Robust and secure information systems
- Systems and processes in place for risk assessment to guide appropriate monitoring of research studies
- Quality systems and standards to support method validation and data reporting
Availability
- A clearly defined process in place through which eligible investigators can access the facilit
A summary of the evaluation criteria which will be used by the expert review panel during the application process can be found in the document below:
Eligibility Criteria Summary
What is the application process for inclusion on the website?
Facilities wishing to be considered for inclusion on the Experimental Medicine Resource Finder website will be required to complete an application form, which are available on the “Eligibility” section of this site. Application forms will be checked for completeness by the NIHR Office for Clinical Research Infrastructure (NOCRI) prior to review by an expert panel.
The expert review panel will be convened by the UKCRC and will include 4-6 representatives from relevant UKCRC Partners. Applications will be reviewed against the specific key competencies and evaluation criteria outlined which cover capability, safety and availability
Facilities that apply will be informed within 6 months of submission, of the panel’s decision.
Successful facilities will be required to agree to the terms for inclusion on the site.
What are the terms of inclusion on the site?
Applicant facilities will be required to agree to the following terms of inclusion:
- A commitment to provide the NOCRI with any additional information required for the facility entry
- A commitment to respond, in a timely fashion, to update requests from the NOCRI
- Use of standardised collaborative research agreements and/or service provision contracts, where available
Who is responsible for updating the information on this site?
The UK Experimental Medicine Resource Finder website is maintained and managed by NOCRI on behalf of UKCRC and their partners. The individual facility information is maintained and updated regularly by their Facility Manager. A governance process is in place to determine whether a new facility or centre is eligible for inclusion on the Resource Finder. For more information about the governance process and the eligibility criteria, please visit the “Eligibility” section of this site.
Who are UKCRC?
The UKCRC was established in 2004 and is a partnership that brings together the major stakeholders that influence clinical research in the UK including the main UK research funding bodies; academia; the NHS; regulatory bodies; the bioscience, healthcare and pharmaceutical industries; and patients. For more information about UKCRC, please visit the “About Us” section of this site.
Who are NOCRI?
The NIHR Office for Clinical Research Infrastructure (NOCRI) help public, charity and industry research funders work in partnership with NIHR infrastructure. NOCRI is also responsible for the re-development and maintenance of the UK Experimental Medicine Resource Finder website. For more information about NOCRI, please visit the “About Us” section of this site.