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Abstract:
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Recently there are many discussions on sample size re-estimation (SSR) design for phase 3 pivotal trials, especially for cancer clinical trials. In SRR, sample size will be increased when interim results fall in a 'promising zone' where it is deemed worthwhile to increase conditional power by adding more subjects. Although SSR has its flexibility on increasing sample size in the middle of the trial, it faces many challenges including controlling type I error rate, requirement on special DMC arrangement and other operation difficulties. In this presentation, we will evaluate a list of important factors which should be considered when choosing SSR design including power, endpoint, enrollment etc.. We will use a hypothetic phase 3 cancer clinical trial design as an example to illustrate the impact of these factors. Some simulation results will be used for illustration.
Disclaimer: The speaker is a paid employee of Astellas. This presentation is intended for informational purposes only and does not replace independent professional judgment. This presentation is not intended to be legal advice.
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