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.
A common reason Phase 2 trials fail is because the RP2D selected from the Phase 1 trial was a sub-therapeutic dose. 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.
In this webinar, the panelists will discuss this issue and its broader implications and highlight alternate Bayesian model-based dose escalation designs that offer a higher chance of selecting an effective therapeutic dose as the RP2D, while also providing greater efficiency than the traditional 3+3 rules-based design and increasing the speed to determining the MTD.
Join expert speakers from Premier Research, Abie Ekangaki, Ph.D., Vice President, Statistical Consulting and Andreas Schreiner, Vice President Medical Affairs Neuroscience & Analgesia in a live webinar on Wednesday, February 24, 2021 at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies.
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