Webinar Slides: Single Arm Registrational Studies in Oncology Research
When developing oncology treatments for patients with no other therapeutic options, single arm registrational studies may be an ethical path to approval. These specialized trial designs supported 31% of new US oncology drug approvals between 2002-2021, proving their value when executed correctly.
However, single arm studies present unique challenges. Without control groups, you must prove efficacy while managing multiple sources of bias. FDA and EMA have different expectations for justifying study design, selecting endpoints, and planning confirmatory studies. Success requires deep understanding of regulatory pathways, statistical considerations, and operational complexity.
This comprehensive webinar guides you through every aspect of single arm registrational studies, from initial concept through regulatory approval. Learn how to establish unmet medical need, select appropriate patient populations, choose defensible endpoints, and implement bias mitigation strategies that satisfy regulatory reviewers.
The webinar features detailed case studies, including how Veristat helped transform early phase findings in an ultra-rare hematologic malignancy into full FDA approval through strategic single arm trial design. You'll also learn about the challenges of multi-regional submissions and how different regulatory authorities approach these complex studies.
Perfect for clinical development leaders, regulatory professionals, biostatisticians, and medical affairs teams working in oncology, especially those developing treatments for rare cancers or later lines of therapy where standard approaches don't apply.
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