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SkyLimit2022

11/22/22 1:08 PM

#537446 RE: dr_lowenstein #537437

Oh yes—it is 100% about crossover. The whole question of crossover is directly related to the elimination of the internal placebo group. When there is no internal control group, external controls must be used. The FDA director’s recent article is highly relevant to the topic of crossover trial design.

Pazdur argues that external controls are both valid and necessary.

https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext