Early phase clinical trials extension to guidelines for the content of statistical analysis plans.
Where this comes from
- Record sourced from PubMed, PMID 35131744.
- Also identified by DOI 10.1136/bmj-2021-068177 and PMC identifier 8819597.
- Licence recorded as CC BY-NC.
- Because redistribution is not established, this page shows the abstract only. Follow the links below for the full text.
Abstract
This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and modifications (25 items) to existing guidance after a review by various stakeholders.
Medical subject headings
- Clinical Trials as Topic
- Data Analysis
- Guidelines as Topic