bio-clinical-biostatistics-trial-reporting

bio-clinical-biostatistics-trial-reporting is a skill for Claude Code, Codex from PKU-YuanGroup/OpenAI4S. It costs 142 tokens per session (9,464 once invoked), scanned A, a copy of bio-clinical-biostatistics-trial-reporting, MIT.

A reporting toolkit for clinical-trial statistics and results. It uses CONSORT, a standard for reporting randomized trials, and ICH E9, guidance for defining exactly which treatment effect a trial estimates.

In plain words
What is it for?
Use it to prepare baseline tables, define analysis populations, describe treatment effects, report missing-data sensitivity analyses, and organize a regulatory-style statistical report.
Why use it?
Trial reports can be hard to compare when they do not clearly define analysis groups, treatment effects, or how missing data was handled. The toolkit provides a structured way to prepare those statistical sections.

Skill for Claude CodeCodex

Written for no agent in particular: nothing here depends on one.

Good fit Use it to prepare baseline tables, define analysis populations, describe treatment effects, report missing-data sensitivity analyses, and organize a regulatory-style statistical report.

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Install with agentmods
npx agentmods add skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-trial-reporting
Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Any agent
npx skills add PKU-YuanGroup/OpenAI4S --skill bio-clinical-biostatistics-trial-reporting
Clone the repo
git clone --depth 1 https://github.com/PKU-YuanGroup/OpenAI4S

Made for: Claude Code, Codex.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

agentmods badge for bio-clinical-biostatistics-trial-reporting

README.md
[![agentmods](https://agentmods.dev/badge/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-trial-reporting/github.svg)](https://agentmods.dev/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-trial-reporting)
Your own site
<a href="https://agentmods.dev/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-trial-reporting"><img src="https://agentmods.dev/badge/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-trial-reporting/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

agentmods 80×15 button for bio-clinical-biostatistics-trial-reporting

Your own site · 80×15
<a href="https://agentmods.dev/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-trial-reporting"><img src="https://agentmods.dev/badge/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-trial-reporting.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 142 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 9,464 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe.
Origin 100% copy Near-identical to another mod in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5.1 $0.00142 $0.09464
Opus 5 $0.00071 $0.04732
Sonnet 5 $0.00028 $0.01893
Haiku 4.5 $0.00014 $0.00946

Measured 9d ago against content hash ca9cd0f6a208, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-12, from the pricing page.

Security

Grade A, and why

bio-clinical-biostatistics-trial-reporting scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 9d ago.

The scan reads SKILL.md. This mod also ships 1 executable file (scripts/trial_reporting_clinical.py), listed below but not scanned — reading those needs a real analyzer, not pattern matching.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

Origin

This is a copy

100% identical to bio-clinical-biostatistics-trial-reporting — 12 lines differ, which has more behind it and is treated as the original. This page carries a canonical link to it rather than competing with it.

skills/bioskills/bio-clinical-biostatistics-trial-reporting/SKILL.md · 478 lines

How it starts

The opening of the file, as written. The whole thing — 478 lines — stays where its author put it; the contents beside it link to each section on GitHub.

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.

The Single Most Important Methodological Shift -- The Estimand Comes First

Kahan, Cro, Li, Harhay 2023 Am J Epidemiol 192:987 ("Eliminating Ambiguous Treatment Effects Using Estimands"): 98% of published trial reports do not describe what the reported treatment effect represents. 54% of trials: impossible to deduce the estimand from reported methods. In 74% of trials submitted for regulatory approval 1996-2017, "what-if" hypothetical effects were used but only 2 trials explained this.

The framework: ICH E9(R1) Addendum (November 2019, EMA effective 30 July 2020, FDA May 2021) defines an estimand as the precise specification of what is being estimated, via five attributes:

  1. Treatment condition -- what is being compared
  2. Population -- which patients
  3. Endpoint -- which variable
  4. Population-level summary measure -- mean diff, OR, HR, RD
  5. Intercurrent-event (ICE) handling strategy -- one of five

Read the full file on GitHub · 478 lines

Files

What ships with it

2 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. 9d ago First seen · 478 lines · 142 tokens per session scan A ca9cd0f6a208

Subscribe to this mod's changes

bio-clinical-biostatistics-trial-reporting is a skill published in the GitHub repository PKU-YuanGroup/OpenAI4S (407 stars, last pushed yesterday), licensed MIT. It adds 142 tokens to every session and 9,464 once invoked, about $0.0007 per session on Opus 5. A static security scan graded it A with 0 findings. It is 100% identical to bio-clinical-biostatistics-trial-reporting, differing in 12 lines, and is treated as a copy.

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