Recent Experiences from CDER Advisory Committee Meetings
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*Lisa Morrissey LaVange, FDA/CDER 

Keywords: Advisory Committees; sensitivity analyses, benefit/risk

Statistical issues that arise in the regulatory review of new drugs and therapeutic biologics will be discussed in the context of recent experiences from CDER Advisory Committee (AC) meetings. Discussion topics include the role of sensitivity analyses in regulatory reviews; the interpretation of differential subgroup effects, such as site effects in multi-regional trials; the assessment of clinical benefit versus statistical significance versus safety risk; and the evaluation of 'strength of evidence.' Process-related aspects of convening and conducting AC meetings will be discussed, including the challenge of identifying AC statisticians and the development of clear questions describing the committee's charge. Metrics summarizing CDER statistical review activities in recent years will also be presented.