Regole della sperimentazione clinica: Rules in clinical experiments

Abstract

Before a new drug can be put on the market, a thorough assessment by governmental bodies is necessary. First of all the drug must overcome a pre-clinical stage including: extraction or synthesis, pharmacological and toxicological study in vitro and on laboratory animals. Permission is then requested from the Ministry of Health to begin experiments on humans. The stages of clinical experiments are also valid for other types of therapeutic procedures such as the association of drugs, surgery and diagnostic investigations or tests. In general all these stages are grouped together in study protocols, which must follow precise rules with regard to their writing out and application if governmental and scientific authorisation is not be denied. However, it is necessary to adapt the protocols to each experimental situation, the one constant point being that experiments should be started very cautiously on a small number of carefully-studied patients in order to arrive at a large-scale assessment.