ClinicalTrials.gov is a publicly accessible registry and results database of publicly and privately supported clinical studies of human participants conducted worldwide. It provides structured information on study design, eligibility criteria, outcomes, locations, recruitment status and results (including adverse events) for interventional and observational studies, as well as expanded access records. The “Study Documents” tab on individual study records allows users to access uploaded documents such as protocols, statistical analysis plans and informed consent forms where available. It can support SAP development by providing reusable templates, that can serve as starting points for new studies, reducing the effort required to draft standard sections.
Statisticians can review how similar trials handled analysis populations, endpoint definitions, missing data, multiplicity, subgroup analyses, and sensitivity analyses.

ECRIN clinical research Metadata Repository (crMDR) is a searchable clinical research metadata portal that enables users to identify clinical studies and linked documents, such as protocols, statistical analysis plans and individual participant datasets, from multiple major international sources. It aggregates metadata on clinical research studies and associated data objects, indicating where results and documents are available and how they can be accessed. Researchers can search by study identifier, paper identifier or keywords and then refine results using structured filters on study and data-object attributes. It can support SAP development by providing reusable templates, that can serve as starting points for new studies, reducing the effort required to draft standard sections.
Statisticians can review how similar trials handled analysis populations, endpoint definitions, missing data, multiplicity, subgroup analyses, and sensitivity analyses.
 

Guideline for the Content of Statistical Analysis Plans (SAPs) in Clinical Trials is a 32‑item checklist defining the minimum recommended content of statistical analysis plans for the final analyses of later‑phase randomised clinical trials. Developed through an extensive, iterative process involving funders, regulatory authorities, journals, industry representatives and UK Clinical Research Collaboration registered Clinical Trial Units, it responds to growing demands for transparency, reproducibility and data sharing in clinical trials. The checklist is intended to be used alongside the clinical trial protocol, consistent with the SPIRIT 2013 Statement, and applied to a clean or validated analysis dataset. A detailed elaboration document provides further explanation of each item, and the guideline is also listed on the EQUATOR Network to support discoverability and implementation. The associated JAMA article offers the full development methodology and formal publication reference. Authored by Gamble et al. and published in JAMA in 2017, this guideline was developed by the Liverpool Clinical Trials Centre at the University of Liverpool, which also hosts the SAP Statement web page, checklist and elaboration document.
 

The ICH E9 (R1) addendum “Estimands and Sensitivity Analysis in Clinical Trials” (EMA/CHMP/ICH/436221/2017) was adopted by the ICH Assembly at Step 4 on 20 November 2019 and came into effect in the European Union on 30 July 2020. It introduces a structured framework to align clinical trial objectives, design, conduct, analysis and interpretation through the explicit definition of estimands: precise descriptions of the treatment effect that reflect how intercurrent events such as treatment discontinuation, rescue medication or death are handled. The addendum describes five main strategies for addressing intercurrent events (treatment policy, hypothetical, composite, while‑on‑treatment and principal stratum) and explains how these choices influence trial design, data collection and analysis. It clarifies the role of sensitivity analysis, which must target the same estimand as the main estimator and is used to assess the robustness of conclusions to deviations from modelling assumptions and data limitations. The principle is that trial protocols should pre‑specify primary and key secondary estimands, aligned estimators and planned sensitivity analyses so that regulators, sponsors and investigators have a shared understanding of what treatment effect is being estimated and how reliable the resulting evidence is for decision making.

The ICH E9 guideline “Statistical Principles for Clinical Trials” is a harmonised tripartite guideline, adopted at Step 4 on 5 February 1998, for marketing applications in Europe, Japan and the United States. It gives direction to sponsors on the design, conduct, analysis and evaluation of clinical trials of an investigational product within its overall clinical development, and supports experts preparing application summaries or assessing evidence of efficacy and safety, mainly from later‑phase confirmatory trials. It sets out core statistical principles for minimising bias and maximising precision, without prescribing specific methods, and assumes that an appropriately qualified statistician is responsible for implementing these principles.