tooluniverse-clinical-trial-design

tooluniverse-clinical-trial-design is a skill for Claude Code from mims-harvard/ToolUniverse. It costs 93 tokens per session (3,001 once invoked), scanned A, original, Apache-2.0.

A feasibility assessment for planning clinical trials. It examines the endpoint, patient population, comparison group, expected treatment effect, study duration, and regulatory route.

In plain words
What is it for?
Choosing endpoints, estimating enrollment, comparing trial designs, assessing duration, and examining possible FDA approval pathways.
Why use it?
It connects protocol choices with likely enrollment needs, approval requirements, and existing trial precedent. This reveals design risks before a study is finalized.

Skill for Claude Code

Written for Claude Code: disable-model-invocation in frontmatter.

Part of the tooluniverse plugin — 140 skills, 8 commands, 1 agent, 1 hook, 1 MCP server shipped together

Good fit Choosing endpoints, estimating enrollment, comparing trial designs, assessing duration, and examining possible FDA approval pathways.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-design
About the project

ToolUniverse is a collection of tools, interfaces, and supporting components for building AI systems that perform scientific work. It is for developers creating AI scientist agents that use APIs, databases, machine-learning tools, and domain-specific utilities. The catalogue includes skills, commands, an MCP server, an agent, and a hook for working with the ecosystem.

mims-harvard/ToolUniverse · 1,680 stars · on GitHub · aiscientist.tools

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 mims-harvard/ToolUniverse --skill tooluniverse-clinical-trial-design
Clone the repo
git clone --depth 1 https://github.com/mims-harvard/ToolUniverse

Made for: Claude Code.

Or install tooluniverse, the plugin that ships this one along with the rest of its 140 skills, 8 commands, 1 agent, 1 hook, 1 MCP server.

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 tooluniverse-clinical-trial-design

README.md
[![agentmods](https://agentmods.dev/badge/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-design/github.svg)](https://agentmods.dev/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-design)
Your own site
<a href="https://agentmods.dev/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-design"><img src="https://agentmods.dev/badge/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-design/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 tooluniverse-clinical-trial-design

Your own site · 80×15
<a href="https://agentmods.dev/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-design"><img src="https://agentmods.dev/badge/skills/mims-harvard/tooluniverse/tooluniverse-clinical-trial-design.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 93 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 3,001 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 1 finding. A grade says what 26 rules found in the file — not that it is safe. Third-party audits
  • Socket pass 29 Mar 2026
  • Snyk warn 29 Mar 2026
  • NVIDIA SkillSpector warn 7 Sept 2026
SkillSpector: 1 finding, up to medium

These are SkillSpector’s own severities. On a checked sample its high-severity flags on skills were ~96% false positives — a documented command, a public API, a “never do X” rule — so we show them as a caution to read, not a verdict. Why →

  • medium Data Exfiltration · line 249
    Data is being sent to an external URL. This could be legitimate telemetry or data exfiltration. Manual review is recommended.
    Fix: Verify the destination URL is trusted and necessary. Remove or replace with documented APIs. Ensure no secrets, tokens, or PII are transmitted.
How audits are shown
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 $0.00093 $0.03001
Opus 5 $0.00046 $0.01501
Sonnet 5 $0.00019 $0.00600
Haiku 4.5 $0.00009 $0.00300

Measured 13d ago against content hash a3f5c0752d24, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-12, from the pricing page.

Security

Grade A, and why

tooluniverse-clinical-trial-design scanned grade A with 1 finding 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 13d ago.

The scan reads SKILL.md. This mod also ships 2 executable files (python_implementation.py, trial_pipeline.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.

Makes network callslowCapability

Not a fault in itself. Listed so you know the mod talks to something, and to what.

resp = requests.get("https://clinicaltrials.gov/api/v2/studies", params=params).json()
plugin/skills/tooluniverse-clinical-trial-design/SKILL.md · 275 lines

How it starts

The opening of the file, as written. The whole thing — 275 lines — stays where its author put it; the contents beside it link to each section on GitHub.

Clinical Trial Design Feasibility Assessment

Systematically assess clinical trial feasibility by analyzing 6 research dimensions. Produces comprehensive feasibility reports with quantitative enrollment projections, endpoint recommendations, and regulatory pathway analysis.

IMPORTANT: Always use English terms in tool calls (drug names, disease names, biomarker names), even if the user writes in another language. Only try original-language terms as a fallback if English returns no results. Respond in the user's language.

Reasoning Before Searching

Trial design starts with the question, not the methods. Answer these four questions before running any tools — they determine everything else:

  1. What is the primary endpoint? Is it overall survival (gold standard but slow), PFS (faster but surrogate), ORR (single-arm friendly but not always accepted), or a biomarker (needs validation as surrogate first)? The endpoint determines FDA pathway, statistical design, and duration.
  2. Who is the population? Broad unselected vs. biomarker-enriched. Enriched populations have higher response rates, allowing smaller trials — but require a validated companion diagnostic and reduce the eligible patient pool.
  3. What is the comparator? Placebo (only if no standard of care exists), active control (requires non-inferiority or superiority framing), or single-arm with historical control (acceptable for rare diseases or breakthrough designations, but FDA scrutiny is high).
  4. Is the effect size realistic given the mechanism? A 20% improvement in ORR over SOC requires ~100 patients per arm. A 50% improvement requires ~30. If the mechanism only justifies a 10% improvement, the trial may be underpowered regardless of design. Check precedent effect sizes in similar trials before committing to an endpoint.

These four answers determine sample size, duration, and trial design. Look them up from precedent trials and FDA guidance — do not derive them from first principles.

Read the full file on GitHub · 275 lines

Files

What ships with it

9 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. 13d ago First seen · 275 lines · 93 tokens per session scan A a3f5c0752d24

Subscribe to this mod's changes

tooluniverse-clinical-trial-design is a skill published in the GitHub repository mims-harvard/ToolUniverse (1,680 stars, last pushed 3d ago), licensed Apache-2.0. It adds 93 tokens to every session and 3,001 once invoked, about $0.0005 per session on Opus 5. A static security scan graded it A with 1 finding (makes network calls). No closer match exists in the catalogue, so it is treated as the original; first seen 2026-08-30.

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