Design and analysis choices for safety surveillance evaluations need to be tuned to the specifics of the hypothesized drug-outcome association

• Susan GruberHarvard University
• Aloka G. ChakravartyUnited States Food and Drug Administration
• Susan R. HeckbertGroup Health Cooperative
• Mark S LevensonUnited States Food and Drug Administration
• David MartinUnited States Food and Drug Administration
• Jennifer C. NelsonKaiser Permanente Washington Health Research Institute
• Bruce M. PsatyGroup Health Cooperative
• Simone P. PinheiroUnited States Food and Drug Administration
• Christian ReichIQVIA (United States)
• Sengwee TohHarvard University
• Alexander Muir Walker