Assessment of adverse drug events during the clinical investigation of a new drug

: Identification and documentation of adverse drug events (ADEs) is an essential prerequisite for the evaluation of the therapeutic value of drug treatment. The present article focuses on the methods used to elicit ADEs during the early drug development phase. These methods vary in the sources of information (patient or physician) used to identify and document ADEs and in the areas (e.g., general scales or special motor performance scales) studied for ADEs.