Early-phase oncology trials are undergoing a fundamental transformation in study design.
For decades, the traditional 3+3 dose escalation method has served as the cornerstone of first-in-human oncology studies. However, with the emergence of targeted therapies, immuno-oncology agents, and cell and gene therapies, this conventional approach is proving increasingly inadequate. Modern oncology demands more statistically robust, adaptive, and patient-centered designs that can better identify an optimal biological dose (OBD)—not merely the maximum tolerated dose (MTD).In this on-demand webinar, Ergomed experts share their insights into how model-assisted and model-based designs are redefining dose escalation and optimization in early-phase oncology. The discussion explores the statistical underpinnings, operational challenges, and regulatory implications of implementing these innovative methods in real-world studies.
Key Discussion Topics
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Why 3+3 designs fall short for modern oncology therapeutics
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How model-assisted or model-based approaches improve dose-finding accuracy and trial efficiency
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Strengths and limitations of Bayesian Optimal Interval (BOIN) and Continual Reassessment Method (CRM)
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Practical considerations for operationalizing adaptive designs
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Best practices for early collaboration between clinical operations and biostatistics teams