This paper examines the objectives of collecting safety data and discusses the evolution of regulatory requirements for safety summarization over the last 30 years. A quick review of the current practice in analyzing safety data is provided and some recent proposals and trends in this area are discussed. The question that must he considered, is whether the analysis that is currently being performed is relevant and whether safety data are being summarized in a way most beneficial to study monitors and investigators in understanding the safety outlook of a new treatment and consequently in selecting a treatment based on the safety data provided in package inserts. Some thoughts are offered.
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