Clinical trials
All medical investigations carried out on human are considered to be a clinical trial which are done at one or more investigation places and have a purpose to search information about one or more medicinal products.
- exploring clinical, pharmacologial and/or pharmacodinamic effects,
- identification of adverse effects triggered by the examined preparation
- examination of absorption, distribution, metabolism and elimination, harmlessness, effectiveness, proving of risk-benefit rate of the preparation (non-invasive examination are not included);
- multi-centered clinical trials with the same investigation plan, but at more than one investigation place in the European Economic Area - EEA, with more than one investigator, and/or in a third country based on an international contract with the EEA or EC where the legal status is the same as in the EEA.
Phase I clinical trial: examination of tolerability, pharmacokinetics, pharmacodinamic effects of the examined preparation on healthy volunteers, or with a preparation with disadvantageous characteristics from the aspect of relative harmlessness on patients who will probably show good response to the preparation.
Phase II clinical trial: examination of the pharmacological effect concerning a particular therapeutic indication with the purpose of proving the therapeutic effect of the preparation, ascertainment of the dose-effect correlation, determination of the optimal single and daily dose, observation of side effects.
Phase III clinical trial: proving of safety of the preparation on numerous patients; controlled, randomized investigation; comparing examinations with medicinal products owning a marketing authorisation.
Phase IV clinical trial: examinations with medicinal products owning a marketing authorisation which have already had authorised therapeutic indications, dose range and approved Summary of Product Characteristics with the aim to collect further information concerning the risk-benefit rate, to adjust dosing and recognize the side effects occuring rarely.
Clinical trials which are carried out without the pharmaceutical industry taking part, by independent investigators from the pharmaceutical industry are not considered to be commercial investigations.
