Abstract
Randomized controlled trials (RCT) are the gold standard study design in order to assess treatment efficacy. However, numerous caveats in RCTs conception might result in various biases (i.e.: selection bias, attrition bias, measurement bias). Furthermore, some statistical issues (i.e.: multiplicity, low power, non-proportional hazards in survival analysis) may also alter RCT conclusion either with false positive or false negative result. Last, inadequate choice of primary outcome might not allow to draw any conclusion with respect to the study question. Thus, randomization quality, blinding of outcome assessment, appropriate choice of primary outcome, number of statistical tests and the fundamental assumptions for survival analyses must be carefully reviewed before analyzing the results of a RCT.© 2021 SPLF. Published by Elsevier Masson SAS. All rights reserved.
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