ArticleContemporary clinical trials communications2023
A template for the authoring of statistical analysis plans.
Article in Contemporary clinical trials communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- Trial
- Data Analysis Planning and Reporting for Confirmatory Multi-Lab Preclinical Trials: A Tutorial.Biometrical journal. Biometrische Zeitschrift · 2026Review
- Clinical Trial Simulation: Planning With the OCTAVE Framework, Implementation and Validation Principles.Statistics in medicine · 2026Article
- Article
- Key statistical recommendations for medical journals: insights from the Global Burden of Disease Study Collaborators.International journal of medical sciences · 2026Article
- A Statistical Analysis Plan Template for Observational Studies: Promoting Quality and Rigor in Research.Journal of statistical theory and practice · 2025Article
- Ten essential tips for robust statistics in cell biology.Nature cell biology · 2025Article
- Biostatistical challenges in multicenter clinical trials: Best practices for collaboration and data harmonization across institutions.Bioinformation · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A number of principal investigators may have limited access to biostatisticians, a lack of biostatistical training, or no requirement to complete a timely statistical analysis plan (SAP). SAPs completed early will identify design or implementation weak points, improve protocols, remove the temptation for p-hacking, and enable proper peer review by stakeholders considering funding the trial. An SAP completed at the same time as the study protocol might be the only comprehensive method for at once optimizing sample size, identifying bias, and applying rigor to study design. This ordered corpus of SAP sections with detailed definitions and a variety of examples represents an omnibus of best practice methods offered by biostatistical practitioners inside and outside of industry. The article presents a protocol template for clinical research design, enabling statisticians, from beginners to advanced.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.