Statistical Considerations for Clinical Trials During COVID-19: Impacts on Permuted Block Randomization and Mitigations

<p> Randomization is the foundation of any randomized controlled trial involving treatment comparisons. The major benefits of randomization in the context of clinical trials are: <ul> <li> Randomization helps mitigate various experimental biases. </li> <li> It promotes comparability of treatment groups with respect to important known and unknown prognostic factors that may be correlated with the primary outcome. </li> <li> It is the basis for the validity of standard statistical tests and makes the underlying assumptions of random sampling more plausible. </li> <li> It can form the basis for statistical inference through re-randomization tests. </li> </ul></p>