In clinical trials, it is not possible to rule out some risks in advance. The tested medicine is usually not studied to the extend allowing for the determination of all of the product properties when used in man. Many risks may be identified on the basis of animal testing of medicines, yet for certain groups of medicines the data obtained from animals are difficult to extrapolate to man. Such groups are, in particular, medicines affecting the immunological mechanisms, influencing specifically “human” enzymatic systems or active in conditions which cannot be modelled in experimental animals.
In no clinical study – and actually not even during regular use - is it possible to guarantee the absolute safety of the medicine. In clinical trials, the participants always have to be informed in advance about the anticipated risks.
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