A clinical trial is a research investigation in a clinical setting, designed to supply data on the efficacy and/or safety of a drug, device, treatment or other healthcare issue. Clinical trials may be sponsored by a governmental organisation, an academic research institute, a non-governmental organisation such as a charity or a manufacturer. Clinical trials are (usually) characterised by clear definition of study hypotheses to be tested, strict inclusion and exclusion criteria, randomisation of study subjects, (where possible) blinded administration of therapy and measurement of outcomes, pre-specified protocols and analysis plans, independent oversight including ethical approval, and comprehensive reporting of results. They can be expensive and lengthy to undertake, and high levels of internal consistency may be achieved at the expense of external generalizability of results to more heterogeneous populations who may receive the intervention in routine practice. Clinical trials of medicines involving human subjects are governed by Good Clinical Practice (ICH-GCP), which enforces tight guidelines on ethical aspects of a clinical study, with high standards for all aspects of trial planning, execution and reporting, backed up by quality assurance and inspections. Clinical trials are recorded in a variety of databases including ClinicalTrials.gov (USA), the EU Clinical Trials Register, and national databases accessed by the WHO International Clinical Trials Registry Platform.
How to cite: Clinical Trial [online]. (2016). York; York Health Economics Consortium; 2016. https://yhec.co.uk/glossary/clinical-trial/