The cost and time of a Phase II trial can be reduced by using a successful adaptive design.
An adaptive phase II trial design can provide an earlier determination of futility and prediction of phase III success. This reduces the overall phase II and III trial sizes whilst shortening overall drug development time.
In this webinar, we will examine two adaptive trial designs that can be applied to your phase II trial design.
Duration: 60 minutes
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MCP-Mod (Multiple Comparisons Procedure - Modelling) is an increasingly popular statistical methodology for dose-finding Phase IIb trials. Since its development at Novartis, MCP-Mod promises to devise proof-of-concept and dose-ranging trials with greater evidence and data that can prove critical for Phase III clinical trial design.
Combining the robustness of multiple comparisons procedures with the flexibility of modelling, MCP-mod combines these methods to provide superior statistical evidence from Phase II trials with regards to dose selection with the FDA & EMA approving MCP-Mod as fit-for-purpose (FFP).
The MCP-Mod methodology has been well developed for the case of normally distributed, homoscedastic data from a parallel group study design. In practice however many other types of endpoints are encountered and often in more complex settings like longitudinal studies for example. Generalized MCP-Mod extends the original MCP-Mod methodology to the context of general parametric models and for general study designs.
Typically, a phase II trial is designed to have a single stage in which a certain number of subjects are treated and the number of successes/responses are observed. However for ethical and economic reasons it may be of interest to stop the trial early, in particular for futility due to high failure rates at Phase II.
Based on the method described in Fleming (1982), the Phase II group sequential test is a one-sided multiple testing procedure that allows for early termination of the study if interim results are extreme. This is done by testing the accrued data at a number of interim stages and looking at the point estimate for the proportion of successes or responses observed at interim points.
Under this design, at each of the interim analyses, the trial may be stopped for futility if the interim cumulative number of successes is below an acceptance point and the trial may be stopped for efficacy if the interim number of successes is above a rejection point. In addition to the ethical benefit, this type of design allows for greater flexibility and cost savings while retaining operating characteristics similar to a fixed term trial.
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