Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies, Upcoming Webinar Hosted by Xtalks
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In this free webinar, attendees will learn about the importance of adopting a suitable dose escalation strategy as well as the benefits and challenges of different dose escalation approaches.
The risk of selecting a sub-therapeutic dose as the RP2D is a key limitation of the traditional 3+3 dose-escalation design in Phase 1. TORONTO (PRWEB) February 08, 2021 Phase 1 clinical trials aim to determine the maximum tolerated dose (MTD) of a new molecule with the goal of identifying a recommended Phase 2 dose (RP2D), often the MTD itself. Ideally, the RP2D would have adequate therapeutic effect to demonstrate preliminary signs of efficacy in Phase 2, but many Phase 2 trials fail to detect a preliminary efficacy signal, prolonging the development program and increasing costs.