Indicator compendium (Interim version).
Many Phase II designs have been proposed, incorporating randomization, interim analyses, adaptation, and patient selection.
At this interim analysis an adaptation may lead to closing the study due to futility, continuing the study without changes or raising the sample size by recruiting an extra r subjects, yielding a total of N = N0 + r subjects.
For the ACT trial design work, the research team set out to develop clinical trials focusing primarily on two broad categories of adaptation, namely, frequent interim analysis and response-adaptive randomization.
First, it contributes to the literature on business model design by showing that specifically designed interim business models facilitate adaptation to and the shaping of the context.
Although a Bayesian model could be used, we choose to use a non-Bayesian final analysis so that the informative prior distributions are only used to guide the adaptation at interim analyses, and the final analysis is only based on data gathered during the trial.
The general process of model-based trial design and analysis is described and several examples demonstrate the value in historical data, simulation-guided design, model-based analysis and trial adaptation informed by interim analysis.
In the interim, I am contemplating an adaptation of my clinic to accommodate the insights and opportunities with which An Epidemic of Absence is replete.
Furthermore, we may apply sample size adaptations based on unblinded interim data.
As first stage test we use the Hochberg test (Hochberg, 1988) such that the first stage p-value is given by The choice of the second stage test depends on the adaptation decisions in the interim analysis.
