bio-clinical-biostatistics-trial-reporting

bio-clinical-biostatistics-trial-reporting is a skill for Claude Code, Codex from GPTomics/bioSkills. It costs 142 tokens per session (9,388 once invoked), scanned A, original, MIT.

A clinical-trial reporting tool for statistical results and study documentation. It follows CONSORT, a reporting standard for randomized trials, and ICH E9 estimand guidance, which defines exactly what treatment effect the analysis targets.

In plain words
What is it for?
Use it to prepare baseline tables, define analysis populations, run adjusted primary analyses, document missing-data strategies, and structure regulatory-style trial reports.
Why use it?
It helps make trial reports consistent, transparent, and easier to assess. It also brings the analysis population, missing-data assumptions, covariate adjustment, and sensitivity checks into the report.

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, run adjusted primary analyses, document missing-data strategies, and structure regulatory-style trial reports.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/gptomics/bioskills/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 GPTomics/bioSkills --skill trial-reporting
Clone the repo
git clone --depth 1 https://github.com/GPTomics/bioSkills

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/gptomics/bioskills/trial-reporting/github.svg)](https://agentmods.dev/skills/gptomics/bioskills/trial-reporting)
Your own site
<a href="https://agentmods.dev/skills/gptomics/bioskills/trial-reporting"><img src="https://agentmods.dev/badge/skills/gptomics/bioskills/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/gptomics/bioskills/trial-reporting"><img src="https://agentmods.dev/badge/skills/gptomics/bioskills/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 9,388 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 original No closer match found 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 $0.09388
Opus 5 $0.00071 $0.04694
Sonnet 5 $0.00028 $0.01878
Haiku 4.5 $0.00014 $0.00939

Measured 6d ago against content hash 93086fa92db0, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-09, 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 6d ago.

The scan reads SKILL.md. This mod also ships 1 executable file (examples/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

Copies of this mod

1 near-identical copy found in the catalogue:

clinical-biostatistics/trial-reporting/SKILL.md · 470 lines

How it starts

The opening of the file, as written. The whole thing — 470 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 · 470 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. 6d ago First seen · 470 lines · 142 tokens per session scan A 93086fa92db0

Subscribe to this mod's changes

bio-clinical-biostatistics-trial-reporting is a skill published in the GitHub repository GPTomics/bioSkills (1,199 stars, last pushed 25d ago), licensed MIT. It adds 142 tokens to every session and 9,388 once invoked, about $0.0007 per session on Opus 5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-09-03.

Related

Other skills, from other repositories

clinical-case-report

Structured medical case presentation for clinical rounds, conferences, and documentation. Generates SOAP-format or narrative case reports with physiologically accurate vitals, labs, and evidence-based plans. Use when the brief mentions "case report", "case presentation", "SOAP note", "clinical case", "ward rounds"…

nexu-io/open-design · 73 tokens

instrument-data-to-allotrope

Convert laboratory instrument output files (PDF, CSV, Excel, TXT) to Allotrope Simple Model (ASM) JSON format or flattened 2D CSV. Use this skill when scientists need to standardize instrument data for LIMS systems, data lakes, or downstream analysis. Supports auto-detection of instrument types. Outputs include full…

anthropics/knowledge-work-plugins · 123 tokens

pydicom

Use pydicom to read, inspect, write, transform, and safely preflight local DICOM datasets and pixel data. Applies to DICOM metadata, transfer syntaxes, compression plugins, frames, private elements, JSON, and bounded de-identification review.

K-Dense-AI/scientific-agent-skills · 56 tokens

nature-experiment-log

A workflow for turning experiment notes, images, audio, or text into structured Markdown laboratory logs with YAML metadata. It can also organize raw attachments and optionally connect the logs to Feishu or Obsidian.

Yuan1z0825/nature-skills · 45 tokens

nature-paper2ppt

A workflow for turning a scientific paper, preprint, PDF, article, figure legends, or reading notes into a complete Chinese PowerPoint presentation. It is designed for journal clubs, group meetings, thesis seminars, conferences, defences, and paper-sharing talks.

Yuan1z0825/nature-skills · 177 tokens

structuring-radiology-reports

Converts free-text radiology narratives into structured findings and impression — with measurements, laterality, anatomy, and follow-up recommendations — after OpenMed NER. Use when the user has a CT/MRI/X-ray/ultrasound/mammography report and needs the sections split (technique, comparison, findings, impression)…

maziyarpanahi/openmed · 195 tokens