Points for Consideration in the Collection and Analysis of Safety Data

Abstract

Because of the overwhelming emphasis on demonstrating efficacy in most clinical trials and the seeming similarity of the scope of safety data across different therapeutic areas, the manner in which safety data should be collected and recorded for a particular study often receives no more attention than that deemed necessary for a routine practice. As for the analysis of the collected data, this has frequently been automated, standardized, and mass-produced in the name of streamlining operations. All of these practices have led to a suppression of the necessary deliberations over whether the current data collection process is cost-effective and whether the safety data collected are being analyzed in a way that best satisfies the needs of the customers. This paper reviews the objectives of safety data collection, points out some problems with the current practice, and raises a number of points for consideration in the area of safety data collection and analysis.