Toronto, ON (PRWEB) September 01, 2022 In clinical research and development, comparison to a control is highly recommended by regulatory agencies for the
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 Phase 1 studies.
Considerations to Improve Patient Outcomes in Early Drug Development, Upcoming Webinar Hosted by Xtalks
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In this free webinar, attendees will learn about developing a framework for handling multiple endpoints for the drug’s go-to-market label and determining the potential of adaptive design for optimizing the trial. The featured speakers will discuss key interactions and questions to ask when seeking regulatory input of pivotal study designs.
A comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes. TORONTO (PRWEB) March 17, 2021 Every drug development program must begin with a thorough identification of all relevant stakeholders patients, physicians, regulators, investors and an understanding of how they factor into the development process. It’s not just a matter of courtesy; a com