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:

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