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Tuesday, November 22, 2022 1:26:24 PM
The use of external control arms in oncology is an evolving
area of methodological advancement and regulatory interest. Thus far, external control data have been limited to
establishing natural history or providing supportive data
analyses affording clinical context for an observed treatment effect. These data have not provided pivotal support
as substantial evidence of treatment effectiveness in
oncology, and therefore have not yet been included in the
prescription drug labeling. In the future, it is possible that
formal analyses for comparative treatment effect between
an investigational therapy and an external control arm
would provide the primary evidence of efficacy to support a
regulatory approval in oncology, particularly for a disease
type with a highly predictable natural history and the precisely measurable treatment effect.
As described in previous sections, t
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