Webinar | Single-Arm Studies for Use as a Registrational Study in Oncology
2023-06-14 · 12:00
Although randomized, controlled clinical trials (RCTs) are the FDA-preferred approach for registrational studies in new drug and biologics development, there are circumstances in oncology wherein a single-arm trial may be appropriate due to disease severity, unmet medical need, and concerns about the feasibility of an RCT. Such settings can expedite the development of new treatments for oncology indications, reduce time to product approval and patient access, and demonstrate clinical benefit of novel product(s) on fewer patients.
Our experts will share their experience in single-arm oncology registrational studies, including successes and lessons learned. 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
Further Information: www.veristat.com/events/citeline...