Abstract:
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When developing a single compound for multiple diseases across various therapeutic areas, planning for the ongoing safety review and aggregate analyses can be challenging. Maintaining consistency across studies for definitions and analyses is necessary. Consistency for unblinded safety review can be achieved with a compound level Data Monitoring Committee, and after studies complete, consistency can be achieved using a comprehensive program safety analysis plan. The discussion will revolve around experiences and best practices when providing ongoing statistical support for safety reviews for the lifecycle of the compound. The following questions, among others, will be discussed: Are multiple disciplines (clinical, safety, statistics, epidemiology, data science) involved in the planning process and when does this planning begin? Are program safety analysis plans being utilized? Are any "safety" treatment effects being estimated that would require a safety-related estimand? When the indications are quite varying in mortality and morbidity, what aspects should be considered when interpreting safety?
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