Problems in Assessing Drug Safety: A Plea for Improved Methodology and a Possible Route

Abstract

Many outsiders do not appreciate the fact that it is not as easy to assess drug safety as drug efficacy. Among the problems in evaluating adverse experiences are the following: confusion over what we are trying to achieve, variability of basic information, difficulty with handling text, unknown hypotheses, large numbers needing to be monitored, necessity for detailed case histories, assigning causality, difficulty in obtaining contrast information, the idea of analysis by “intention to treat,” evaluating the data base, no agreement on significance levels, and the hostility of the environment in which decisions are made. We must pool ideas and agree on a strategy.