Webinar: Adaptive Dose-Finding Designs Improving Drug Development Strategies
In this webinar Cytel Consulting Statistician, Jim Bolognese shares his considerable Phase 2 development experience first with a brief overview of Adaptive Design before revealing how a single adaptive dose-finding design can replace the traditional sequence of 2 separate non-adaptive-trials (PoC high-dose vs. placebo trial followed by a dose-finding trial).
Complete this form to access the webinar replay and downloadable slides to see how simulations can evaluate the likely performance characteristics of a dose-finding design under consideration. Various adaptive options are contrasted to inform on the types of dose-finding objectives that can be efficiently addressed; the designs include:
- T-statistic-based Up & Down
- Bayesian 4-parameter logistic model
- Bayesian Normal Dynamic Linear Model (NDLM)
- Maximizing
- 2-stage dropping dose(s)
What You Will Learn
- How to assess the usefulness of particular design options
- Scenarios for applying a variety of adaptive approaches including Seamless Phase 2b / 3 trials, 2-stage designs and frequent adaptation approaches
- Types of adaptive dose-finding design algorithms
- How adaptive designs can yield better quality information about the dose response curve
- Better understand the context of adaptive designs in regulatory submissions
Topic and speaker resources:
- Read research paper Simulations for optimizing clinical trial programs published by Bolognese and colleagues at Cytel
- Recent FDA News briefing on adaptive trials
- More on Jim and the Cytel Strategic Consulting team members