Guideline for the Content of Statistical Analysis Plans in Clinical Trials

This guideline sets out a structured framework for planning, documenting and reporting statistical methods in clinical trials, via a minimum set of 32 items to be addressed in a statistical analysis plan (SAP). It reduces variation in practice and promotes transparent, prospective specification of analyses in later‑phase randomised clinical trials, ensuring alignment between the SAP, the trial protocol and the SPIRIT 2013 Statement. It is particularly useful for investigator‑initiated clinical studies that require robust, funder‑ and journal‑acceptable SAPs to support reproducible analyses and clear reporting.

The SAP Statement web page provides:

• A concise overview of the rationale for the guideline
• The scope and assumptions underlying the 32‑item checklist
• Direct links to all supporting materials

From this page, users can:

• Download the 32‑item SAP checklist for later‑phase randomised clinical trials, covering key elements such as title, objectives and hypotheses, analysis populations, outcome definitions, statistical methods, handling of missing data, subgroup and sensitivity analyses, and harms
• Access the elaboration document, which explains each item, provides rationale and includes guidance text and illustrative examples
• Navigate to the JAMA guideline article describing the development methodology, including literature review, surveys of current practice and consensus‑building across stakeholders
• Find the reporting‑guideline style entry on the EQUATOR Network, with bibliographic details and links to the full‑text article and supporting documents
• The resource offers a peer‑reviewed, consensus‑based minimum standard for SAP content that can be applied across disease areas and trial settings. It helps investigators and trial statisticians to pre‑specify and document critical aspects of planned analyses, align the SAP with the protocol, and minimise the risk of selective analysis or outcome switching. A practical way to begin is to use the checklist to draft or review the SAP structure, then consult the elaboration document for clarification on individual items, and use the JAMA article as the formal reference in protocols, funding applications and publications.