Clinical Trials and their Importance in Assessing the Efficacy and Safety of Psychotropic Drugs

Prior to 1962, trials of new medications were largely based on a series of uncontrolled testimonials by clinicians associated with the studies. The change in the conduct of clinical trials arose largely in response to the public concern, and that of the medical profession, expressed as a result of the thalidomide disaster in which thousands of women in Europe produced offspring with serious limb deformations which occurred after taking the drug for the treatment of morning sickness during the first trimester of pregnancy. This tragedy resulted in the establishment of regulatory authorities in most European countries who established legal guidelines, mainly based on those of the Food and Drug Administration in the USA, which ensured that all new drugs would be subjected to adequate pre-clinical and clinical assessment before they could be marketed. This is not the place to describe in detail the pre-clinical and clinical studies which are now required by the Medicine Boards which were established by the European Commission to ensure that optimal standards are reached before any drug is made available for clinical use. However, the following summary will hopefully serve to illustrate the procedures involved in ensuring the efficacy and safety of drugs.

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