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Operationalizing Adaptive Design for FDA's One-Trial Era
October 20, 2026 : 11:00 AM ET
On February 18, 2026, the FDA signaled a major shift, accepting a single pivotal trial plus confirmatory evidence as the new default pathway to approval. For sponsors and clinical development teams, that raises an immediate question: how do you actually design a trial to meet that bar?
Adaptive clinical trial designs are built for exactly this moment. Because they let a study evolve in real time based on accumulating data, they're a natural fit for the new standard. In this session, Veristat's adaptive design experts walk through what it actually takes to make this work in practice: the statistical frameworks behind a defensible single pivotal trial, how to navigate FDA expectations along the way, and a real case study where adaptive design cut both timeline and cost without cutting corners on quality.
If you're planning a pivotal trial right now, or still figuring out whether the One-Trial pathway makes sense for your program, this session is built to give you something practical to walk away with, not just theory.
Key Learning Objectives
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Understand how the FDA's February 2026 One-Trial policy shift changes pivotal trial design and evidentiary expectations
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Learn the statistical frameworks and regulatory strategies needed to build an adaptive trial that meets the new single-pivotal-trial standard
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See real-world evidence of how adaptive design has reduced development timelines and costs while preserving trial quality
About the Speaker
Dr. Louis Martos
Director, Project Management, Veristat
Louis Martos, MD, MBA, is a clinical research and global trial operations leader with over 20 years of experience directing complex Phase I–III studies across pharmaceutical, biotechnology, CRO, and academic research environments. Combining medical training with business and operational leadership, he has overseen large-scale international programs from feasibility and site selection through closeout and archival, with accountability for delivery, quality, risk mitigation, financial oversight, and patient safety.
Dr. Martos has led cross-functional global teams and partnered with sponsors, investigators, physicians, medical staff, and executive stakeholders to advance clinical development programs across oncology, hematology, rare disease, vaccines, immunology, neurology, pain management, and health outcomes research. Known for translating complex clinical and operational priorities into clear, actionable strategy, he brings a disciplined, collaborative approach to study execution, stakeholder communication, regulatory alignment, and timely delivery of high-quality clinical results.