Beyond 3+3: Rethinking Early-Phase Oncology Study Design, Upcoming Webinar Hosted by Xtalks

In this free webinar, understand why traditional 3+3 dose escalation designs are increasingly unsuitable for modern oncology drug development. Attendees will learn how model-assisted (e.g., Bayesian Optimal Interval Design) and model-based (e.g., Continual Reassessment Method) approaches improve dose-finding accuracy, efficiency and patient safety. The featured speakers will discuss the statistical foundations and operational implications of adaptive dose-escalation designs. Attendees will identify the strengths, limitations and regulatory considerations for different methodologies. The speakers will share practical insights into implementing adaptive designs, including team collaboration, data flow and decision-making processes. Attendees will discover best practices for fostering early and ongoing cooperation between clinical operations and biostatistics to ensure trial success.

TORONTO, Sept. 30, 2025 /PRNewswire/ — Early-phase oncology trials are undergoing a fundamental shift in study design. Traditional 3+3 dose escalation methods, which have long been the standard for first-in-human cancer studies, are increasingly being replaced by more statistically robust, adaptive designs. This transition is driven by the rise of targeted therapies, evolving regulatory expectations and the need to more accurately identify an optimal biological dose (OBD) rather than simply the maximum tolerated dose (MTD).

In this webinar, the featured speakers will engage in a dynamic conversation exploring both the statistical underpinnings and operational realities of model-assisted or model-based approaches to dose escalation and optimization. The discussion will highlight the drivers behind this shift, the strengths and limitations of various escalation methods and key considerations for implementing these models to balance safety, efficiency and regulatory compliance.

Topics will include:

• Why 3+3 designs fall short for modern oncology therapeutics
• How model-assisted or model-based approaches improve dose-finding accuracy and trial efficiency
• Strengths and limitations of Bayesian Optimal Interval Design (BOIN) and Continual Reassessment Method (CRM)
• Key considerations for operationalizing these study designs
• Best practices for early and ongoing collaboration between clinical operations and biostatistics teams

Register for this webinar to learn how replacing 3+3 dose escalation improves early-phase oncology trial design and outcomes.

Join experts from Ergomed, Bin Pan, PhD, Executive Director of Operational Strategy; and Adam Jacobs, Executive Director and Strategic Consultant, Biostatistics, for the live webinar on Friday, October 10, 2025, at 10am EDT (4pm CEST/EU-Central).

For more information or to register for this event, visit Beyond 3+3: Rethinking Early-Phase Oncology Study Design.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks, visit www.xtalks.com
For information about hosting a webinar, visit www.xtalks.com/why-host-a-webinar/

Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: vkovacevic@xtalks.com

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SOURCE Xtalks