Single-Arm Studies for Use as a Registrational Study in Oncology
In this webinar presentation, you will learn about when it may be appropriate to pursue a single-arm registrational study that can expedite the development of new treatments for oncology indications, reduce time to product approval and patient access, and demonstrate the clinical benefit of novel product(s) on fewer patients.
The following considerations will be discussed during the webinar:
How to know if there is an unmet medical need that may allow for a single-arm registrational study
How to develop a single-arm study design for registration, including:
- Defining the population
- Selecting study endpoints and defining a clinically meaningful benefit
How to determine a regulatory strategy, including:
- Accelerated approval vs. full approval
- Planning for agency interaction – when and how to approach the US FDA and what key questions to ask
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