- •Modifications of trial design after initiation can undermine scientific validity.
- •Design changes were identified in most drug trials published in influential journals.
- •Most modifications were not reported in the related publications.
- •Justification for such modifications should be reported more clearly.
Abbreviations:CI (confidence intervals), HR (hazard ratio), IQR (interquartile range), FDA (Food and Drug Administration), OR (odds ratios), RCT (randomized controlled trial)
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