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Abstract:
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Standardized study data are now a required component of new drug applications to the US Food and Drug Administration (FDA). However, standardized data should not be created solely for an FDA submission. Industry statisticians in particular have an enormous amount to gain from early access to standardized data, particularly analysis data sets that conform to the CDISC ADaM model. In this talk, the role of statisticians in the creation of standardized study data for FDA submissions will be discussed in addition to the benefits that statisticians can gain from having access to standardized data early in the conduct of a clinical trial and across an entire development program.
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