Explore Single-Arm Registrational Studies in Oncology Research
Navigate Complex Regulatory Pathways and Design Trials That Deliver Approvals for Patients with Unmet Medical Needs
When randomized controlled trials aren't ethical or feasible, single-arm registrational studies may offer a critical pathway to bring life-saving oncology treatments to market. But success requires deep expertise in regulatory strategy, statistical design, and bias mitigation.
Join Robin Bliss, PhD, Vice President of Strategic Consulting at Veristat, as she guides you through the foundations of successful single arm trials, from defining patient populations and establishing unmet medical need to securing FDA and EMA approvals.
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What You'll Learn:
✔ When single-arm designs are appropriate and how to justify their use to regulators
✔ Key regulatory differences between FDA and EMA approaches
✔ Critical design elements: population selection, endpoint selection, and sample size determination
✔ Proven strategies for identifying and mitigating bias in single arm studies
✔ Real-world case study: How we turned early phase findings into full FDA approval
✔ Best practices for accelerated approval and conditional authorization pathways
Who Should Attend:
- Clinical Development Leaders
- Regulatory Affairs Professionals
- Biostatisticians
- Medical Affairs Teams
- Oncology Program Managers
- Operations teams supporting rare cancer trials
About the Speaker
Robin Bliss brings extensive experience in oncology clinical development, biostatistics and regulatory strategy. In this webinar, she shares lessons from real programs, including a case study where early-phase findings were transformed into FDA approval through single-arm trial design. She has guided many sponsors in evaluating whether single-arm studies are appropriate for registration, offering insights on when and how this approach can accelerate market entry.
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