about the workshop
A Seminar on New Approaches to Dose-Finding Using Adaptive Trials
Designers of phase II dose ranging studies are challenged to find the right doses to carry forward to late stage development.
Adaptive dose finding designs enable investigation of more doses without increasing the sample size. Employing adaptive dose-finding approaches can significantly improve the development process while using similar or smaller subjects compared to conventional, fixed trials.
The FDA's recently issued draft guidelines specifically encourage the use adaptive designs especially in the learning stage of clinical development. The EMA's position is quite similar.
But exactly how would a trial planning team today go about the process of selecting the best adaptation strategy and trial design method for determining the best dose level to use in final stages of development?
Using case studies and Cytel's latest design tools, we examine how adaptive dose-finding is today helping biopharmaceutical companies of all sizes determine the optimal dose for the registration phase.
what's covered?
A review of the factors to take into account in selecting a successful dose finding trial:
- The importance of considering both frequentist and Bayesian designs when selecting the best design for an adaptive dose finding clinical trial; both methodologies having been successfully deployed in dose finding trials
- As neither frequentist nor Bayesian approaches dominates the other in practice, an examination of the advantages and disadvantages with both trial types
- Using trial simulation to compare and confidently determine the best adaptive dose-finding trial design
Scroll down for the full programme...
an example:
Accomplishing multiple objectives in a single study
Adaptive dose-finding designs can accomplish multiple objectives in a single study. Alternatives to the traditional paradigm of multiple, individual clinical trials each requiring their own resources and their requisite start-stop gaps between studies.
Now, a single adaptive trial can replace multiple conventional studies and use fewer total subjects in the process. For example, we can construct one study to effectively cover what traditionally development approaches would have required three separate trials:
1. 1/2 Proof-of-Concept Study to demonstrate that the drug works as intended
2. Phase 2a Dose-Finding Study to estimate the dose-response relationship
3. Phase 2b Dose-Response Study to choose the dose(s) for phase 3 trials
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