Post-submission changes to prespecified statistical analysis plans

Transparency and reproducibility are two of the fundamental principles of evidence generation and dissemination of research knowledge.12 Researchers ask questions, challenge answers, replicate results, and scrutinise findings—this is how we accumulate knowledge and help develop evidence based policy. Scientific integrity, reliability, reproducibility, and transparency are paramount if scientific studies are to serve as the basis for policies that can have a big effect on human wellbeing.3Detailed guidelines on writing a prespecified research protocol and statistical analysis plan have been developed to improve the transparency and reproducibility of research.456 Prespecified plans have a critical role in minimising and detecting selective analysis and reporting.78The BMJ requires authors of clinical trials to upload their protocol and statistical analysis plans during submission, and encourages it for other study types. The protocols and analysis plans of all accepted studies are published alongside their findings.9 This is to reassure readers that the analysis was honest, did…
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