In order to ensure the validity of results of randomised clinical trials and under some circumstances to optimise statistical power, most statistical methods require validation of underlying statistical assumptions. The present paper describes how trialists in major medical journals report tests of underlying statistical assumptions when analysing results of randomised clinical trials. We also consider possible solutions how to improve current practice by adequate reporting of tests of underlying statistical assumptions. We conclude that there is a need to reach consensus on which underlying assumptions should be assessed, how these underlying assumptions should be assessed and what should be done if the underlying assumptions are violated.
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Contributors All authors developed the framework and participated in writing the article. EEN is the guarantor of the article. All remaining authors are selected statistical experts, methodologists and trialists from different parts of the world.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.