Definition clinical study, clinical trial and low-intervention clinical trial
The CTR provides a definition of a “clinical study”, of a “clinical trial” and of a “low-intervention clinical trial” (article 2.2 and 2.3):
A clinical study means any investigation in relation to humans intended:
- to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products; and/or
- to identify any adverse reactions to one or more medicinal products; and/or
- to study the absorption, distribution, metabolism and excretion of one or more medicinal products; with the objective of ascertaining the safety and/or efficacy of those medicinal products.
A clinical trial means a clinical study which fulfils any of the following conditions:
- 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;
- the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study;
- diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.
Low-intervention clinical trial
A low-intervention clinical trial means a clinical trial which fulfils all of the following conditions:
- the investigational medicinal products, excluding placebos, are authorised; and
- according to the protocol of the clinical trial,
- the investigational medicinal products are used in accordance with the terms of the marketing authorisation; or
- the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and
- the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned.