Hemming, K;
Kearney, A;
Gamble, C;
Li, T;
Jüni, P;
Chan, A-W;
Sydes, MR;
(2020)
Prospective reporting of statistical analysis plans for randomised controlled trials.
Trials
, 21
(1)
, Article 898. 10.1186/s13063-020-04828-8.
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Abstract
In 2017, JAMA published a statistical analysis plan (SAP) guidance document for randomised clinical trials (RCTs). This guidance is part of the EQUATOR Network of reporting resources and includes a checklist of minimum items for reporting details of statistical analysis of RCTs [1]. While the clinical trial protocol should describe the principal features of the statistical analysis, a separate detailed SAP containing sufficient information to support replication by an independent statistician may be needed [2,3,4].
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