[Clinical trials of drugs without immediate therapeutic objectives]

Clinical trials without immediate therapeutic objectives are performed in phases I and III of drug testing. In phase I, the studies in a small number of healthy volunteers provide information about tolerance, dosage, pharmacokinetics and often, about the principal effects. In phase III, the therapeutic value of the drug has been demonstrated, and the aims are to determine the circumstances which increase the risk of iatrogenicity. These trial are carried out in elderly patients and in those with hepatic or renal failure. In addition, information about drug interactions may be required for the AMM report. Examples are given to illustrate these principles. The author recall the conditions which must be strictly adhered to in the execution of these trials.