The following outline is provided as an overview of and topical guide to clinical research:
Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans.
General topics
Clinical significance – a conclusion that an intervention has an effect that is of practical meaning to patients Drug discovery – the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy Drug development – the process of taking a new chemical through the stages necessary to allow testing in clinical trials Biotechnology – the technological application that uses biological systems, living organisms to make or modify products or processes for specific use Biopharmaceutical – a drug produced using biotechnology Clinical trial – an experiment with human subjects to assess safety and efficacy of drugs Academic clinical trials – clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities) Clinical trials unit – biomedical research units dedicated to conducting clinical trials Epidemiology – the study of factors affecting the health and illness of populations Epidemiological methods – statistical techniques used in epidemiology Evidence-based medicine – the assessment of the quality of evidence relevant to the risks and benefits of medical treatments Pharmacology – the study of the interactions that occur between a living organism and drugs that alter normal biochemical function Biopharmacology – the pharmacology of biopharmaceuticals Clinical pharmacology – the scientific discipline focused on rational drug development and utilization in therapeutics Pharmacokinetics – the study of the fate of drugs administered to the body Bioequivalence – the biological equivalence of two preparations of a drug Pharmacodynamics – the study of the biochemical and physiological effects of drugs on the body Pharmacometrics – the science of interpreting and describing pharmacology in a quantitative fashion Pharmacovigilance – the detection, assessment, understanding and prevention of adverse effects of medicines
Drug terminology
Active ingredient – the substance in a drug that is pharmaceutically active
Approved drug – a drug that has been approved for marketing by a regulatory body such as the U.S. Food and Drug Administration or the European Medicines Agency Excipient – an inactive substance used as a carrier for the active ingredients of a drug Medicinal product – any substance or combination of substances used for treating or preventing disease in humans Off-label use – the practice of prescribing a drug for an indication for which the drug has not been approved Orphan drug – a drug used to treat a rare medical condition, or orphan disease Placebo – a sham treatment given to a control group in a clinical study Prescription drug – a licensed medicine that can only be obtained by prescription from a doctor Standard treatment – a currently available drug used in an active control clinical study
Types of study design
Clinical study design
Blind experiment
Case report
Case series
Case study
Case-control study
Clinical control group
Cohort study
Cross-sectional study
Crossover study
First-in-man study
Longitudinal study
Minimisation
Multicenter trial
Nested case-control study
Observational study
Open-label trial
Placebo-controlled studies
Prospective cohort study
Randomized controlled trial
Retrospective cohort study
Run-in period
Seeding trial
Vaccine trial
Study participant confidentiality and safety
Human subject research
Adverse drug reaction
Adverse event
Council for International Organizations of Medical Sciences
Data confidentiality in clinical trials
Data monitoring committees
Ethics Committee (European Union) EudraVigilance Exclusion criteria Great ape research ban Inclusion criteria Institutional review board MedWatch Safety monitoring Serious adverse event Suspected Adverse Reaction Surveillance Scheme