Clinical Trial
ICH GCP – Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy (As per Section 1.12 of ICH E6(R2))
EU: Clinical Trials Directive – Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy. This includes clinical trials carried out in either one site or multiple sites, whether in one or more than one Member State (As per Article 2(a) of Directive 2001/20/EC)
EU: Clinical Trials Regulation – Means a clinical study which fulfils any of the following conditions:
(a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;
(b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
(c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.
(as per Article 2.2(2) of Regulation (EU) No 536/2014)
USA: FDA’s Framework for Real-World Evidence Program – A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Clinical trials are interventional clinical studies (as per Glossary of Framework for FDA’s Real-World Evidence Program – Dec 2018)
USA: 45 CFR 46 – Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes (as per 45 CFR 46.102(b))
USA: clinicaltrials.gov – Another name for an interventional study (as per Clinicaltrials.gov – Glossary)
USA: 42 CFR 11 – Clinical trial means a clinical investigation or a clinical study in which human subject(s) are prospectively assigned, according to a protocol, to one or more interventions (or no intervention) to evaluate the effect(s) of the intervention(s) on biomedical or health-related outcomes (as per 42 CFR 11.10)
Note: 42 CFR 11 (Clinical Trials Registration and Results Information Submission) defines the clinical trial registration requirements for clinicaltrials.gov
China: Key Considerations in Using Real-World Evidence to Support Drug Development – An interventional clinical research in which one or more interventions, possibly including placebo or other controls, are prospectively assigned to human subjects to assess the impact of these interventions on health-related biomedical or behavioral outcomes (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019)
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