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Abstract:
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Sponsors are recommended to develop a Program Safety Analysis Plan (PSAP) for products in clinical development (Crowe BJ et al. Clinical Trials 2009; 6:430-440). The PSAP is a living document which proactively specifies the plan for the statistical analysis of the product safety data and, for products in development, is the predecessor of the statistical analysis plan for the Summary of Clinical Safety. The PSAP has 2 main sections: a standard data collection plan and an analytical section. Building upon the important concepts in the PSAP, an Aggregate Safety Analysis Plan (ASAP) is now proposed to meet the changing landscape of safety assessment expectations and regulatory reporting requirements. The proposed ASAP would support: 1) Description of the evolving product safety profile including subpopulations and safety topics of interest; 2) Plans for future safety data collection and integration including a gap analysis for important missing information; 3) Signal detection activities and components of the FDA proposed "Safety Surveillance Plan" and 4) External communication of safety data.
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