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Abstract:
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No-one denies the importance of examining adverse event data in a clinical trial, yet this data is usually presented as simple incidence, or in some cases, incidence rates for each preferred term, SOC and overall. One reason is that adverse event data presents several real statistical challenges. A key challenge is multiplicity due to the large number of different preferred terms as well as the possible need to monitor adverse events over time. The interpretation of the terms themselves is also important, as the implication of 3 headaches and 3 cancers are clearly different. The context of the population under study, exposure time, and disease state are all things that may put adverse event rates into context, however, incorporating them into an analysis presents further challenges. Summarizing the results of the ASA Working Group on Safety Monitoring work on this topic, we provide an overview of different techniques available for this analysis, and explain how they may be applied to help provide a more considered framework for evaluating adverse event data.
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