Abbreviations
CTU: Clinical Trials Unit
eRDC: Electronic Remote Data Capture
MHRA: Medicines & Healthcare products Regulatory Agency
NCRI: National Cancer Research Institute
NHS: National Health Service
NIHR: National Institute for Health Research
NIHR CRN CC: NIHR Clinical Research Network Coordinating Centre
NRES: National Research Ethics Service
PROs: Patient Reported Outcomes
RCT: Randomised Controlled Trial
UKCRC: UK Clinical Research Collaboration
UKCRN: UK Clinical Research Network
Methodological Research Categories
Biomarker Research: Evaluation of clinical parameters that reflect a physiological state in relation to health or disease and/or drug treatment status. Different types of biomarkers could be stratification markers that predict drug response; efficacy biomarkers that predict a clinical outcome, toxicity biomarkers that predict toxic effects, screening markers for early detection of disease or prognostic markers that predict the likely course of a disease.
Complex interventions: Research into the evaluation of complex interventions. Complex interventions are interventions which are built up from a number of active components. The components may include behaviours (e.g. how often something is done and when) and methods of organising or delivering behaviours (e.g. setting for the intervention). The complex intervention could be at the level of individual patient, at health professional level, at service level or at population level.
Economic evaluation: The comparative analysis of alternative courses of action in terms of both costs and consequences. The basis is a comparison of costs and benefits of an drug/treatment or intervention.
IT Systems: Research into the information technology systems that can be used to design trials/studies, collect, monitor, analyse, present and interpret data from clinical trials/studies.
Outcome measures: Evaluation and review of the measures used in clinical research studies and how these are interpreted . Studies of this type would also include those addressing the use of patient reported outcomes (PRO) in clinical research.
Qualitative research: Largely exploratory research aiming to gather an in depth understanding of human behaviour and the reasons governing that behaviour. A body of research techniques which seeks insight through mainly verbal data rather than measurement.
Recruitment and retention issues: Research which seeks to evaluate different approaches to the recruitment and retention of patients into clinical trials/studies.
Statistical methods: Research into methods of collecting, monitoring, analysing, presenting and interpreting data.
Systematic Reviews and Meta analysis: A systematic review is a literature review focused on a single question which aims to identify, appraise and synthesize all high quality evidence relevant to that question. A meta analysis is an analysis which combines results from several studies that address a set of related research hypotheses.
Trial design: Research into the most appropriate trial design to address the research question.
Study Type Categories
Clinical Trial of an Investigational Medicinal Product (CTIMP) Phase I: A small scale trial of an investigational medicinal product tested for the first time in man to investigate safety and dose finding of a new drug/treatment.
Clinical Trial of an Investigational Medicinal Product (CTIMP) Phase II: A small scale trial of an investigational medicinal product, usually single arm, to investigate the safety and efficacy of a new drug/treatment.
Clinical Trial of an Investigational Medicinal Product (CTIMP) Phase III: A larger scale trial of an investigational medicinal product to compare new drug/treatment against a standard to determine effectiveness and further safety evaluation.
Clinical Trial of an Investigational Medicinal Product (CTIMP) Phase IV: A post-marketing evaluation of an investigational medicinal product to collect information about its use in different populations and on any side effects associated with longer term or wider use.
Disease management studies: Studies which evaluate disease management strategies.
Diagnostic Studies: Studies which establish the diagnostic accuracy of the test or evaluate the impact of one or more diagnostic strategies on therapy decisions and/or patient outcomes.
E-Health: Evaluation of a healthcare practice that is supported by electronic processes and communications. E-health describes the application of information technology across the whole range of functions within the health sector e.g. doctor, manager, administrators and patients.
Epidemiology: the study of factors affecting the health and illness of populations, and serves as the foundation and logic of interventions made in the interest of public health and preventive medicine. It is considered a cornerstone methodology of public health research, and is highly regarded in evidence-based medicine for identifying risk factors for disease and determining optimal treatment approaches to clinical practice.
Experimental medicine: Studies in which an intervention is undertaken in human beings to identify the cause of disease and to test the validity and importance of new discoveries.
Feasibility: a preliminary study undertaken to determine and document a trial/study's viability. The results of this study are usually used to make a decision whether or not to proceed with further trials/studies.
Imaging: Studies to investigate the role of imaging in the diagnosis of disease or on therapy decisions.
Medical devices: a trial/study to evaluate an object which is useful for diagnostic or therapeutic purposes. More specifically the EU Directive 2007/47/EC defines a medical device as "any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."
Paediatrics: Trials/studies in children (aged between 0-17 years)
Primary care: Trials/studies assessing drugs/treatments or interventions based within primary care.
Psychological and behavioural: Evaluation of interventions that are psychologically based or aim to influence behaviour.
Radiotherapy: Trials/studies that evaluate radiotherapy.
Screening: Trials/studies that evaluate different approaches to screening patients for treatment or disease.
Surgery: Trials/studies that evaluate surgical techniques.
CTU Registration Status Categories
Full registration: Required CTUs to demonstrate a track record and experience of coordinating multi-centre randomised controlled trials or other well-designed studies; presence of a core team of expert staff to develop studies; presence of robust quality assurance systems and processes to meet appropriate regulations and legislation; and evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio.
Full registration (also NCRI Accredited): CTUs which were already accredited by the National Cancer Research Institute (NCRI) for the conduct of multi-centre cancer clinical trials automatically became eligible for Full UKCRC Registration provided that they agreed to commit to the UKCRC Registered Trials Units best practice principles.
Provisional registration: Awarded to newer and evolving CTUs that did not meet the criteria for Full Registration status, but which have relevant expertise and experience that is worth building on, and are working towards possessing sufficient expertise to enable Full Registration in the future.