Lilly Program Safety Analysis Plan Implementation and Bayesian Dose Response
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*Wei Wang, Eli Lilly And Company 

Keywords: SPERT, Program Safety Analysis Plan, PSAP, Bayesian, Dose Response

I will share our experience implementing the Safety Planning, Evaluation and Reporting Team (SPERT) recommendation to develop a program safety analysis plan (PSAP) as a tool to proactively plan for meta-analysis of the program safety data. We focused on improving existing processes rather than building a brand new process. Our PSAP is an analytical plan for meta-analysis that is developed in conjunction with a program-level data collection plan. By providing a guidance document for the PSAP, we improved the consistency and efficiency of safety data analysis and were able to efficiently communicate and implement some innovative analytical methods for meta-analysis of safety data. I will also present a Bayesian dose response method for safety meta-analysis that appropriately analyzes dose response, without requiring all trials included in the analysis to have the same doses studied.