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On Quantitative Methods for Clinical Safety Monitoring in Drug Development

ABSTRACT Safety monitoring and reporting has achieved a greater level of attention in the past 15 years. Statisticians play an important role in learning about a drug's safety profile. An ASA safety monitoring working group was established with a goal to empower the biostatistics community to play a proactive role and better enable quantification in safety monitoring. As part of its effort, this article presents a systematic review and unique perspective on the existing methodology developments, which include Bayesian and frequentist, blinded versus unblinded safety monitoring, individual versus aggregate data meta-analyses, pre-, and post-marketing methods, static versus dynamic safety reviews, and methods of visualization. These perspectives may serve as a background for future statistical work, both in methodology development and its application.