Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

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guidelines-for-the-content-of-statistical-analysis-plans-in-clinical-trials

While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility. Recommendations are provided for a minimum set of items that should be addressed and included in SAPs for clinical trials. Trial registration, protocols, and statistical analysis plans are critically important in ensuring appropriate reporting of clinical trials.

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