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.
Speakers
Bin Pan, PhD, Executive Director of Operational Strategy, Ergomed
With 25 years of experience in clinical research and a strong focus on oncology clinical development, Bin brings a wealth of expertise and leadership. Her professional journey spans roles with increasing responsibilities in clinical operations, trial management, oversight and operational strategy, working across pharma, biotech and CRO companies.
Bin earned her PhD in Molecular Biology, which provided her with a deep understanding of scientific principles and a strong foundation for advancing innovative treatments. She is passionate about the advancements in precision medicine and immuno-oncology that have transformed the treatment landscape. Yet, she recognizes that patients, particularly those suffering from rare cancers, still face significant unmet needs.
Message Presenter
Adam Jacobs, Executive Director and Strategic Consultant, Biostatistics, Ergomed
Adam is a Statistician with extensive experience in clinical research and statistics leadership and is the Head of Biostatistics and Programming at Ergomed. He had previously set up and run his own company, in which he led a team of medical writers, clinical data managers and statisticians and had a senior leadership position in the biostatistics department at another global CRO. He has worked on a broad range of medical statistics, primarily in clinical trials, including clinical pharmacology, pharmacokinetics, efficacy trials, adaptive designs and epidemiological databases. He has had experience in many therapeutic areas; however, the fields in which he has worked more extensively include oncology, pain management, rare diseases and neurology. He holds degrees in Medical Statistics, Natural Sciences, Organic Chemistry and Social Sciences.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Clinical Operations Professionals involved in oncology trials and study execution
- Biostatisticians and Statistical Programmers supporting dose-finding studies
- Clinical Development & Medical Directors shaping early-phase oncology strategies
- Regulatory Affairs Specialists ensuring compliance with evolving guidance
- Project Managers overseeing early-phase trial delivery
- Translational Scientists and Pharmacologists contributing to dose selection decisions
- Oncology R&D Leaders interested in optimizing early-phase trial outcomes
What You Will Learn
Attendees will:
- Understand why traditional 3+3 dose escalation designs are increasingly unsuitable for modern oncology drug development
- Learn how model-assisted (e.g., BOIN) and model-based (e.g., CRM) approaches improve dose-finding accuracy, efficiency and patient safety
- Explore the statistical foundations and operational implications of adaptive dose-escalation designs
- Identify the strengths, limitations and regulatory considerations for different methodologies
- Gain practical insights into implementing adaptive designs, including team collaboration, data flow and decision-making processes
- Discover best practices for fostering early and ongoing cooperation between clinical operations and biostatistics to ensure trial success
Xtalks Partner
Ergomed
Established in 1997, Ergomed is a global leader in delivering specialized services in oncology, rare disease, and complex trials to the pharmaceutical and biotech sectors. Our comprehensive support covers the entire clinical trial process, from early phase to post-approval, offering full-service, industry-leading clinical trial management solutions as a trusted partner. Our integrated service model helps life sciences companies meet regulatory obligations, maximize drug development success, and enhance the patient experience.
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