Coaxing ADaM data into formats useful for review by both clinical and statistical reviewers
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ADaM datasets offer a predictable standard for analysis data but not all data fits easily into this model. In addition, the model may not provide data in a format that helps reviewers answer regulatory questions. With examples, this talk will illustrate how the ADaM structure is helpful to reviewers and describe improvements that may be needed to promote the advantages of using ADaM datasets for the review of NDA/BLA data.