bio-clinical-biostatistics-adaptive-designs

bio-clinical-biostatistics-adaptive-designs is a skill for Claude Code, Codex from PKU-YuanGroup/OpenAI4S. It costs 147 tokens per session (7,781 once invoked), scanned A, a copy of bio-clinical-biostatistics-adaptive-designs, MIT.

A guide to adaptive clinical trials, where planned interim results can change the sample size, treatment groups, or enrolled population while the study is running.

In plain words
What is it for?
Designing group-sequential studies, sample-size reassessment, treatment selection, population enrichment, and seamless Phase 2/3 trials.
Why use it?
It helps researchers make these changes according to a pre-planned statistical design while controlling the risk of a false positive result.

Skill for Claude CodeCodex

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

Good fit Designing group-sequential studies, sample-size reassessment, treatment selection, population enrichment, and seamless Phase 2/3 trials.

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Install with agentmods
npx agentmods add skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-adaptive-designs
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-adaptive-designs
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-adaptive-designs

README.md
[![agentmods](https://agentmods.dev/badge/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-adaptive-designs/github.svg)](https://agentmods.dev/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-adaptive-designs)
Your own site
<a href="https://agentmods.dev/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-adaptive-designs"><img src="https://agentmods.dev/badge/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-adaptive-designs/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-adaptive-designs

Your own site · 80×15
<a href="https://agentmods.dev/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-adaptive-designs"><img src="https://agentmods.dev/badge/skills/pku-yuangroup/openai4s/bio-clinical-biostatistics-adaptive-designs.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 147 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 7,781 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 97% 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 $0.00147 $0.07781
Opus 5 $0.00073 $0.03890
Sonnet 5 $0.00029 $0.01556
Haiku 4.5 $0.00015 $0.00778

Measured 9d ago against content hash a8614f0850d0, 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-adaptive-designs 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.

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

97% identical to bio-clinical-biostatistics-adaptive-designs — 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-adaptive-designs/SKILL.md · 459 lines

How it starts

The opening of the file, as written. The whole thing — 459 lines — stays where its author put it; the contents beside it link to each section on GitHub.

Version Compatibility

Reference examples tested with: R rpact 4.2+ (Wassmer/Brannath), gsDesign 3.6+ and gsDesign2 1.1+ (Anderson/Merck), adaptr, simtrial. Commercial: East/EastHorizon (Cytel), ADDPLAN (ICON), FACTS (Berry Consultants).

Before using code patterns, verify installed versions match. If versions differ:

  • R: packageVersion('<pkg>') then ?function_name
  • Python adaptive packages are limited; R is the regulatory de facto standard

If code throws an error, introspect the installed package and adapt the example to match the actual API rather than retrying.

Adaptive Clinical Trial Designs

"Design an adaptive trial" -> Pre-specify a design with one or more interim adaptations (early stopping, sample-size re-estimation, treatment selection, population enrichment, randomisation ratio changes) that strongly controls Type-I error at the trial-wide level via combination tests or the Conditional Rejection Probability principle.

Regulatory Status -- The 2024-2026 Landscape

FDA 2019 Final Adaptive Designs Guidance (Federal Register 2019-25986, Dec 2 2019) finalised the 2010 and 2018 drafts. Recognises 5 design types: group-sequential, blinded SSR, unblinded SSR, adaptive enrichment, adaptive randomisation.

FDA 2022 Final Master Protocols Guidance (March 2022, NOT 2018 — common citation error): basket (one drug, many diseases), umbrella (multiple drugs, one disease), platform (perpetual, drugs enter/exit).

ICH E20 Adaptive Clinical Trials: Step 2b draft June 25 2025; Step 3 public consultation (EU deadline Nov 30 2025; FDA Federal Register Sept 30 2025); Step 4 final expected in 2026. As of May 2026, ICH E20 is NOT final. The EFPIA/PhRMA position paper preceded the formal ICH work; Berry Consultants public comment letter is one of the more important submissions.

FDA CDER Bayesian Methodology Draft (Jan 2026) (FDA-2025-D-3217): first-ever drug-side Bayesian guidance; permits Bayesian primary inference in pivotals with simulation-based Type-I error calibration.

Read the full file on GitHub · 459 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 · 459 lines · 147 tokens per session scan A a8614f0850d0

Subscribe to this mod's changes

bio-clinical-biostatistics-adaptive-designs is a skill published in the GitHub repository PKU-YuanGroup/OpenAI4S (407 stars, last pushed yesterday), licensed MIT. It adds 147 tokens to every session and 7,781 once invoked, about $0.0007 per session on Opus 5. A static security scan graded it A with 0 findings. It is 97% identical to bio-clinical-biostatistics-adaptive-designs, differing in 12 lines, and is treated as a copy.

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