A note on penalty-free interim analyses of clinical studies with binary responses |
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Authors: | Chen Cong |
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Institution: | Merck Research Laboratories, BL 3-2, PO Box 4, West Point, PA 19486, USA. Cong_chen@merck.com |
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Abstract: | In oncology studies with binary responses, it is often desirable to demonstrate the anti-tumor activity of a test drug before the planned study completes. We propose penalty-free interim analysis strategies that do not change the rejection criterion for the test of null hypothesis at the end. The strategies are applied to standard one-arm and two-arm studies. Although the motivating studies are from oncology, the findings in this research note are equally applicable to similar settings. A broad list of references is provide to stimulate further research on the topic. |
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Keywords: | Exact test Group sequential method Oncology Sequential test Two‐stage design |
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