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Pre‐specification of the primary analysis model is a pre‐requisite to control the family‐wise type‐I‐error rate (T1E) at the intended level in confirmatory clinical trials. However, mixed models for repeated measures (MMRM) have been shown to be poorly specified in study protocols. The magnitude of a resulting T1E rate inflation is still unknown. This investigation aims to quantify the magnitude of...
The COVID‐19 pandemic has manifold impacts on clinical trials. In response, drug regulatory agencies and public health bodies have issued guidance on how to assess potential impacts on ongoing clinical trials and stress the importance of a risk‐assessment as a pre‐requisite for modifications to the clinical trial conduct. This article presents a simulation study to assess the impact on the power of...
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