Individual skill
bio-clinical-biostatistics-trial-reporting
Prepares statistical reports for clinical trials following CONSORT 2025, SPIRIT 2025, ICH E9(R1) estimands, and FDA 2023 covariate adjustment guidance. Covers Table 1 generation, analysis populations (ITT/FAS/PP/Safety), the 5 ICH E9(R1) intercurrent-event strategies, MMRM under MAR (mmrm), reference-based MI (rbmi J2R/CR/CIR), Permutt tipping-point sensitivity, and Rubin's-rules vs frequentist variance debate. Use when preparing regulatory submissions, defining estimands, or implementing missing-data sensitivity analyses.
skills/bioskills/bio-clinical-biostatistics-trial-reporting/SKILL.md
Source commit ef85836a0b900799d7d478593080a84d64a86d8c
What was checked
- Matches the observed repository HEAD
- Yes
- Scanner rules are current
- No
- Repository scan complete
- No
- Skill scan complete
- No
- Observed behavior
- Not checked yet
- Last checked
- Nov 4, 2026
These are observations at the recorded commit, not a guarantee of safety. Review the source before running it.
Install this skill
Choose an agent in your Stack or copy a command below. Commands fetch the pinned commit and copy only this skill directory. Existing destinations are refused. Copying a command does not install anything.
An install command is unavailable: current rules, complete repository and skill scans, an eligible behavior level and a permitted license are required.
Repository context
- Repository stars (not skill ratings)
- 663
- Repository last updated
- Nov 8, 2026
- License
- MIT
Observed agent integration: No specific integration evidence. Standard SKILL.md installation does not imply verified compatibility.
- agent Repository topic
- ai4science Repository topic
- claude-science Repository topic
- mit-license Repository topic
- open-source Repository topic
- science-research Repository topic
- legal Derived category
- data Derived category
Files and excerpt
File metadata and permitted, redacted excerpts come from the recorded scan. Source links are pinned to that commit.
Browse files
SKILL.mdcore · 38,011 bytesSKILL.mdcore · 38,011 bytesSKILL.mdcore · 38,011 bytesSKILL.mdcore · 38,011 bytesSKILL.mdcore · 38,011 bytesSKILL.mdcore · 38,011 bytesSKILL.mdcore · 38,011 bytesreferences/usage-guide.mddoc · 7,938 bytesscripts/trial_reporting_clinical.pyruns · 4,365 bytes
Read excerpt
## Version Compatibility
Reference examples tested with: tableone 0.9+, statsmodels 0.14+, scikit-learn 1.4+, pandas 2.1+, numpy 1.26+. R packages cited (essential for current regulatory work): mmrm 0.3+ (Roche/openpharma), rbmi 1.5+ (Roche/Bayer via insightsengineering), gMCP, RBesT.
Before using code patterns, verify installed versions match. If versions differ:
- Python: `pip show <package>` then `help(module.function)` to check signatures
- R: `packageVersion('<pkg>')` then `?function_name`
If code throws ImportError, AttributeError, or TypeError, introspect the installed package and adapt the example to match the actual API rather than retrying.
# Trial Reporting Under CONSORT 2025 + ICH E9(R1)
**"Prepare a clinical trial statistical report"** -> Define the estimand explicitly per ICH E9(R1); execute a covariate-adjusted primary analysis targeting the right summary measure; pre-specify the missing-data strategy and run regulatory-grade sensitivity analyses; structure the output per CONSORT 2025 and the new SPIRIT 2025 alignment.
