Strategies for a Label Claim or Indication in the Context of Robust Point Estimates From Historical Data

For label claims or indications, especially in the US, prospectively designed clinical trials are usually required. However, when robust data are available and indicate a nearly unmistakable performance of the product of interest, the post hoc analysis should be seriously considered for the label claim or indication purpose. In this article, post hoc, Bayesian, and stand-alone new trial analyses are discussed and compared so that under such situations, a decision-making process could be facilitated.