Abstract
While postmarketing surveillance of adverse drug reactions (ADRs) has received wide attention in recent years, ADR and side effect assessment in clinical trials is an area which deserves further investigation. Despite the logic of a systematic approach to ADR detection from preclinical work through postmarketing monitoring, no such system exists. By increasing sensitivity, reliability and validity of ADR measurement, such a scheme would more effectively protect patients from dangerous drugs, assist the clinician by providing comparison data on adverse reactions of psychotropic agents, and improve comparability of experimental results across testing centers. We have focussed our inquiry on the assessment of ADRs in clinical trials. Expectations of such testing should be geared to the statistical realities of practical sample sizes. Within reason, such sample sizes could be altered in accord with anticipated frequencies of certain ADRs. In addition, laboratory standards for both low and high frequency reactions would assist consensus in defining particular ADRs. Agreement among investigators as to one or two useful ADR rating instruments would eliminate the large number of non-standard, often inadequate instruments now in use. Such an assessment instrument could be geared toward completeness, ease of execution and an effective data analysis. Objective measurement on a limited basis would be of further assistance. It is of critical importance for changes in adverse drug reaction methodology to truly assist the clinical researcher, without encumbering him with excessive guidelines and forms. Such a methodology should complement the clinical observation and rational approach which are basic elements of clinical observation.