Adaptive Designs For Early Phase Development: Are The Questions Right?

By Esha Senchaudhuri

In 2005, Pfizer launched a Phase 1 trial for the kinase inhibitor crizotinib. Six years later, it was approved, thanks in no small part to an early phase adaptation made in 2007 which enabled it to demonstrate efficacy merely a few years later.

According to James Matcham, VP of Strategic Consulting at Cytel, the accelerated approval rate shows how critical it is to plan adaptations early in the development journey. In a recent webinar hosted by Cytel’s Shanghai office, James reviews essential new innovations in methods related to dose-escalation for single and combination studies; decision-making for portfolio selection; dose-finding; and enrichment designs. In evaluating these adaptations, James also encourages us to consider several new questions to ask in our overall approach to early phase development.