Jan 27

Clinical trials Development : Studies classification

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) recommends to classify clinical trial studies accordingly to their objectives.

Studies classification
Studies can be classified into four different types, accordingly to their objectives.

1.Human Pharmacology: Human pharmacology studies objectives are

– to assess how well tolerated by human subjects is the new compound;
– to define and describe the pharmakinetics (e.g. how much of the drug is absorbed, where the drug distributes in the human body, how fast is the drug excreted), the pharmacodynamics ( e.g. what are the mechanisms of action of the new compound);
– to explore the drug metabolism (biological processes) and interactions (e.g. with other proteins);
– and finally to estimate the drug activity.

General examples of human pharmacology studies are dose-tolerance studies, single and multiple dose PK and/or PD studies, drug interaction studies.

2.Therapeutic exploratory: Therapeutic exploratory studies objectives are

– to to explore use of the drug for the targeted indication;
– to estimate what is the needed dosage for subsequent studies,
– to provide a basis for subsequent study designs, endpoints (such as improvements in quality of life, relief of symptoms), methodologies

General examples of therapeutic exploratory studies are dose-response exploration studies or early trials of relatively short duration in small well-defined populations using endpoints/clinical measures

3.Therapeutic confirmatory: Therapeutic confirmatory studies are used –

– to demonstrate/confirm efficacy of the new compound;
– to establish a safety profile of the drug;
– to provide an adequate basis to assess the benefits and the risks associated to the new drugs to support the drug approval for release on the market
– to establish a dose-response relationship

General examples of therapeutic confirmatory studies are randomised parallel dose-response studies, studies of mortality and morbidity outcomes or comparative studies

4.Therapeutic use: Therapeutic use studies objectives are

– to ameliorate the understanding of the benefits and the risks of the new compound general relationships or those associated to specific populations or environments;
– to identify the less common sides effects
– to refine the dosing recommendation

Generals examples of therapeutic use studies are comparative effectiveness studies, mortality/morbidity outcomes studies or pharmacoeconomic studies

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(1) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Topic 8
(2) Health Canada
(3) U.S. Food and Drug Administration (FDA)

For more information, visit Clinical Trials Info.

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