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Article | April 26, 2021 5 Key Takeaways: Insights On Alternative Designs To The Traditional 3+3 Design In Phase 1 Dose Escalation Studies By Abie Ekangaki and Andreas Schreiner Traditionally, Phase 1 trials commonly utilize 3+3 designs to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Studies have shown, however, that two out of three trials employing a 3+3 design failed in identifying the MTD, and better approaches are needed.1 During Premier Research’s recent webinar Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies, Abie Ekangaki, Vice President, Statistical Consulting, and Andreas Schreiner, Vice President, Medical Affairs, Neuroscience & Analgesia, discuss alternative dose-escalation paradigms introduced into the clinical trial landscape for Phase 1 trials. In this blog post, we share five of their key insights on alternative dose escalation strategies for ....
Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies, Upcoming Webinar Hosted by Xtalks Share Article 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 increasi ....