Guidelines for the Management of Adverse Events Occurring during Clinical Trials

Abstract

Good Clinical Practice requires the investigator to report to the sponsor the serious adverse events occurring during clinical trials with a new drug but does not concern the management of these events. In this paper, a special investigator's brochure is presented dealing with the seven following adverse events:neutropenia, thrombocytopenia, anemia, increase in aminotransferases, acute renal failure, proteinuria, and skin disorders. For each event, a definition is drawn from national or international consensus meetings on adverse drug reactions and a flow-chart is proposed for the clinical management. The threshold for either intensive monitoring or interruption of the drug administration has been determined to minimize the risk to which the patient is exposed. The main examinations are listed in order to collect on a special record form early data indispensable for causality assessment and detection of the risk factors. The use of this brochure for three years has considerably helped the work of the clinical investigators and improved the early and adequate documentation of adverse events contributing then to the decision to carry on or to discontinue the development of a new compound.