In this free webinar, the featured speakers from Premier Research will discuss considerations for maximizing enrollment, finding the right investigational sites, and choosing a suitable dose-escalation study design for your first-in-human oncology trial. They will also examine the use of medical informatics to predict enrollment rates and experienced phase 1 trial sites via proprietary and public domain sources. This allows sponsors to project accurate timelines, anticipate enrollment rates, and identify potential sites. Attendees will also learn about selecting sites based on their expertise in conducting multicenter phase 1 oncology dose-finding studies, trial-specific relevant capabilities at the site, and local regulations. In addition, the speakers will highlight various dose-escalation designs for determination of dose for next trials (e.g., recommended phase 2 dosing).
TORONTO (PRWEB) NOVEMBER 02, 2020
Setting up an effective phase 1 trial for a novel investigational oncology product is rife with challenges. Every aspect, from site identification to estimation and coordination of enrollment and safety review, is interrelated to ensure a timely dose determination that is nimble and allows flexibility.
What factors can affect, or even derail, the timeline? How can you identify the key influencers and experienced sites? Does a potential site have the requisite expertise in multicenter dose escalation studies and the experience, equipment, and investigational product handling capabilities to collect the patient pharmacokinetic and pharmacodynamic biomarker samples that are critical in defining safety and mechanism of action for your novel product? What options are available for a suitable dose-escalation design strategy: Rules-based design (e.g., 3+3 or Rolling-6) or Model-based design (e.g., CRM, etc.)?
In this webinar, speakers will provide a detailed checklist of the key factors to consider in both the US and the EU.
Join expert speakers from Premier Research, Peter Larson, MD, Vice President, Medical Affairs; Meghan Shea, Manager and Solutions Lead; Federica Vinciati, PhD, Senior Regulatory Start-Up Manager; and Abie Ekangaki, PhD, Vice President, Statistical Consulting for a live webinar on Monday, November 9, 2020 at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Dosing Strategies to Improve Early-Phase Oncology Study Design.
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Topic: Oncology Phase 1 Trials: The Importance of Site Selection and Dosing Strategies in Early-Phase Oncol (Read 122 times)