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Adaptive Trial Design for Phase 1 Dose-Finding Studies
ON DEMAND WEBINAR
Duration: 1 hour
Greater flexibility, efficiency and quicker dissemination of research findings to patient communities that stand to benefit are all potential advantages of adaptive trial design as compared to more conventional methods such as 3+3. Novel adaptive approaches are particularly relevant with respect to dose finding and dose optimization in early Oncology development.
In this webinar, we’ll focus on the use of adaptive design approaches in Oncology phase 1 dose-finding studies. For context, our presenters will discuss the evolution of early Oncology development, persistent challenges and recent initiatives, such the FDA’s Project Optimus, that strive to balance efficacy, efficiency and ethical concerns in the pursuit of bringing promising new therapies to patients. Several case studies will be presented to illustrate the value adaptive approaches offer in terms of sample size re-estimation, determining the maximum tolerable dose for future trials, terminating study arms early based on interim results, and enabling more rapid decisions without sacrificing validity.
The webinar examines adaptive design from a multi-disciplinary perspective by incorporating clinical development, modeling and biostatistics. In the webinar’s final section, our presenters explore the interplay between statistical analysis and planned adaptations, trial assumptions and restrictions. By attending this webinar, you will learn:
- Advantages of adaptive trial design approaches as compared to conventional methods in Phase 1 Oncology dose finding studies
- How novel adaptive approaches enable more rapid decisions in practice through a series of case studies
- Considerations for a statistical analysis plan and the importance of sustained statistical support to account for planned study modifications
SPEAKERS
Drug Development Solutions
Senior Director, Clinical Pharmacology and Translational Medicine
Integrated Drug Development
Founder and President
Mediana
