Maximum type I error rate inflation from sample size reassessment when investigators are blind to treatment labels
Consider a parallel group trial for the comparison of an experimental treatment to a control, where the second‐stage sample size may depend on the blinded primary endpoint data as well as on additional blinded data from a secondary endpoint. For the setting of normally distributed endpoints, we demo...
| Main Authors: | , , |
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| Format: | Online |
| Language: | English |
| Published: |
John Wiley and Sons Inc.
2015
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| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4851240/ |
| Summary: | Consider a parallel group trial for the comparison of an experimental treatment to a control, where the second‐stage sample size may depend on the blinded primary endpoint data as well as on additional blinded data from a secondary endpoint. For the setting of normally distributed endpoints, we demonstrate that this may lead to an inflation of the type I error rate if the null hypothesis holds for the primary but not the secondary endpoint. |
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