Agent skill

Tooluniverse Clinical Trial Design

by aipoch in aipoch/medical-research-skills

Strategic clinical trial design feasibility assessment using ToolUniverse.

MITAuto-check passedResearch & Science

Install Tooluniverse Clinical Trial Design

skills CLI
$ npx skills add aipoch/medical-research-skills --skill tooluniverse-clinical-trial-design -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install aipoch/medical-research-skills tooluniverse-clinical-trial-design --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/aipoch/medical-research-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/'scientific-skills/Protocol Design/tooluniverse-clinical-trial-design' .claude/skills/tooluniverse-clinical-trial-design && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
tooluniverse-clinical-trial-design
GitHub stars
1.9k
Token cost
~2.6k tokens
SKILL.md length
720 words
Files
14 (incl. references)
Skills in repo
578
Repo updated
First seen
Licence
MIT

At a glance

Strategic clinical trial design feasibility assessment using ToolUniverse.

  • Works in 12 steps: Report-First Approach (MANDATORY) → Evidence Grading System → Feasibility Score (0-100) → …
  • Tasks that involve Experimental design
  • SKILL.md covers Core Principles, When to Use This Skill, Quick Start and Core Strategy: 6 Research Paths, plus 4 more sections
  • Runs Python scripts from its folder

What it does

Tooluniverse Clinical Trial Design is an agent skill from aipoch/medical-research-skills. Strategic clinical trial design feasibility assessment using ToolUniverse. Evaluates patient population sizing, biomarker prevalence, endpoint selection, comparator analysis, safety monitoring, and regulatory pathways. Creates comprehensive feasibility reports with evidence gr...

Its SKILL.md is about 2.6k tokens, which your agent loads only when the skill is triggered. The skill folder holds 14 other files, including reference files (for example `EXAMPLES.md`, `POLISH_CHANGELOG.md` and `QUICK_START.md`).

It sits in Research & Science, covering Experimental design, Clinical and healthcare research and Legal research. The repository describes itself as: Hundreds of agent skills for medical research, including protocol design, data analysis, evidence insights, and academic writing. The licence is MIT.

When your agent uses it

  • Tasks that involve Experimental design
  • Tasks that involve Clinical and healthcare research
  • Tasks that involve Legal research

Example prompts

  • “/tooluniverse-clinical-trial-design”

Requirements

  • Python 3

Workflow steps

12 steps, taken from the step headings in SKILL.md.

  1. Report-First Approach (MANDATORY)
  2. Evidence Grading System
  3. Feasibility Score (0-100)
  4. Executive Summary
  5. Disease Background — Indication, prevalence, SOC, unmet need
  6. Patient Population Analysis — Funnel model with enrollment projections
  7. Biomarker Strategy — Prevalence, CDx, logistics
  8. Endpoint Selection & Justification — Primary/secondary/exploratory with evidence grades
  9. Comparator Analysis — SOC, design options, drug sourcing
  10. Safety Endpoints & Monitoring Plan — DLT, toxicities, organ monitoring, SMC
  11. Study Design Recommendations — Phase, schema, eligibility, treatment plan, schedule
  12. Enrollment & Site Strategy — Site selection, projections, recruitment

What it can do on your machine

Read from SKILL.md and the folder at commit 686e09d. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    Ships script files (Python), which the agent can run.

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

Context cost

Tooluniverse Clinical Trial Design loads about 2.6k tokens when it runs, and up to ~14k if it reads all its reference files. Until then it costs about 79 tokens; SKILL.md has 720 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~79
When it runs · the whole SKILL.md, loaded when a task matches
~2.6k
With references · SKILL.md plus every file in references/, read only if the agent opens them
~14k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); files beside SKILL.md are not scanned.

SKILL.md

The full file from aipoch/medical-research-skills at commit 686e09d, republished under its MIT licence (© aipoch). 720 words, ~2,621 tokens.

Download SKILL.mdSave it as .claude/skills/tooluniverse-clinical-trial-design/SKILL.md (or your agent's skills folder). This skill also uses 13 other files; get the full folder from GitHub.
name
tooluniverse-clinical-trial-design
description
Strategic clinical trial design feasibility assessment using ToolUniverse. Evaluates patient population sizing, biomarker prevalence, endpoint selection, comparator analysis, safety monitoring, and regulatory pathways. Creates comprehensive feasibility reports with evidence gr...
license
MIT
author
AIPOCH

Source: https://github.com/aipoch/medical-research-skills

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.

Core Principles

1. Report-First Approach (MANDATORY)

DO NOT show tool outputs to user. Instead:

  1. Create [INDICATION]_trial_feasibility_report.md FIRST
  2. Initialize with all section headers
  3. Progressively update as data arrives
  4. Present only the final report
2. Evidence Grading System
GradeSymbolCriteriaExamples
A★★★Regulatory acceptance, multiple precedentsFDA-approved endpoint in same indication
B★★☆Clinical validation, single precedentPhase 3 trial in related indication
C★☆☆Preclinical or exploratoryPhase 1 use, biomarker validation ongoing
D☆☆☆Proposed, no validationNovel endpoint, no precedent
3. Feasibility Score (0-100)

Weighted composite score:

  • Patient Availability (30%): Population size × biomarker prevalence × geography
  • Endpoint Precedent (25%): Historical use, regulatory acceptance
  • Regulatory Clarity (20%): Pathway defined, precedents exist
  • Comparator Feasibility (15%): Standard of care availability
  • Safety Monitoring (10%): Known risks, monitoring established

Interpretation: ≥75 = HIGH (proceed) | 50-74 = MODERATE (validate) | <50 = LOW (de-risk)

→ Detailed scoring rules: references/scoring_and_endpoints.md


When to Use This Skill

Apply when users:

  • Plan early-phase trials (Phase 1/2 emphasis)
  • Need enrollment feasibility assessment
  • Design biomarker-selected trials
  • Evaluate endpoint strategies
  • Assess regulatory pathways
  • Compare trial design options
  • Need safety monitoring plans

Trigger phrases: "clinical trial design", "trial feasibility", "enrollment projections", "endpoint selection", "trial planning", "Phase 1/2 design", "basket trial", "biomarker trial"

NOT for:

  • Patient-to-trial matching → use tooluniverse-clinical-trial-matching
  • Phase 3/4 confirmatory trial design → needs specialized biostatistics consultation
  • Post-market surveillance or pharmacovigilance → use tooluniverse-adverse-event-detection
  • Regulatory submission document preparation → use specialized regulatory affairs tools

Quick Start

python
from tooluniverse import ToolUniverse

tu = ToolUniverse(use_cache=True)
tu.load_tools()

# Example: EGFR+ NSCLC trial feasibility
indication = "EGFR-mutant non-small cell lung cancer"
biomarker = "EGFR L858R"

# Step 1: Get disease prevalence
disease_info = tu.tools.OpenTargets_get_disease_id_description_by_name(
    diseaseName="non-small cell lung cancer"
)

# Step 2: Estimate biomarker prevalence
variants = tu.tools.ClinVar_search_variants(gene="EGFR", significance="pathogenic")

# Step 3: Find precedent trials
trials = tu.tools.search_clinical_trials(
    condition="EGFR positive non-small cell lung cancer",
    status="completed", phase="2"
)

# Step 4: Identify standard of care comparator
soc_drugs = tu.tools.FDA_OrangeBook_search_drugs(ingredient="osimertinib")

# Compile into feasibility report...

Core Strategy: 6 Research Paths

Execute 6 parallel research dimensions:

Trial Design Query (e.g., "EGFR+ NSCLC trial, Phase 2, ORR endpoint")
│
├─ PATH 1: Patient Population Sizing
│   Disease prevalence → Biomarker prevalence → Eligibility funnel → Enrollment projection
│
├─ PATH 2: Biomarker Prevalence & Testing
│   Mutation frequency → CDx availability → Turnaround time → Alternative biomarkers
│
├─ PATH 3: Comparator Selection
│   Standard of care → Approved comparators → Historical controls → Placebo appropriateness
│
├─ PATH 4: Endpoint Selection
│   Primary endpoint precedents → FDA acceptance → Measurement feasibility → Surrogate vs clinical
│
├─ PATH 5: Safety Endpoints & Monitoring
│   Mechanism-based toxicity → Class effects → Organ monitoring → SMC plan
│
└─ PATH 6: Regulatory Pathway
    Regulatory precedents → Breakthrough potential → Orphan designation → FDA guidance

→ Detailed execution instructions & tool calls: references/research_paths_detail.md


Report Structure (14 Sections)

Create [INDICATION]_trial_feasibility_report.md with:

1. Executive Summary
markdown
# Clinical Trial Feasibility Report: [INDICATION]
**Date**: [YYYY-MM-DD] | **Trial Type**: [Phase 1/2] | **Primary Endpoint**: [ORR]
**Feasibility Score**: [0-100] - [LOW/MODERATE/HIGH]

## Key Findings
- **Patient Availability**: [Est. enrollable patients/year]
- **Enrollment Timeline**: [Months to target N]
- **Endpoint Precedent**: [Grade A/B/C/D]
- **Regulatory Pathway**: [505(b)(1), breakthrough, orphan]
- **Critical Risks**: [Top 3]

## Go/No-Go Recommendation
[RECOMMEND PROCEED / ADDITIONAL VALIDATION / DO NOT RECOMMEND]
2. Disease Background — Indication, prevalence, SOC, unmet need
3. Patient Population Analysis — Funnel model with enrollment projections
4. Biomarker Strategy — Prevalence, CDx, logistics
5. Endpoint Selection & Justification — Primary/secondary/exploratory with evidence grades
6. Comparator Analysis — SOC, design options, drug sourcing
7. Safety Endpoints & Monitoring Plan — DLT, toxicities, organ monitoring, SMC
8. Study Design Recommendations — Phase, schema, eligibility, treatment plan, schedule
9. Enrollment & Site Strategy — Site selection, projections, recruitment
10. Regulatory Pathway — FDA pathway, precedents, pre-IND, IND timeline
11. Budget & Resource Considerations — Cost drivers, FTE requirements
12. Risk Assessment — Feasibility risks, scientific risks, mitigation
13. Success Criteria & Go/No-Go Decision — Phase 1/2 criteria, scorecard
14. Recommendations & Next Steps — Final recommendation, critical path, alternatives

→ Detailed section templates: references/research_paths_detail.md


Show full SKILL.md (283 more words)Show less

Feasibility Scorecard Template

markdown
| Dimension | Weight | Score (0-10) | Weighted | Grade |
|-----------|--------|--------------|----------|-------|
| Patient Availability | 30% | [X] | [0.30×X] | [★★☆] |
| Endpoint Precedent | 25% | [X] | [0.25×X] | [★★★] |
| Regulatory Clarity | 20% | [X] | [0.20×X] | [★★☆] |
| Comparator Feasibility | 15% | [X] | [0.15×X] | [★★★] |
| Safety Monitoring | 10% | [X] | [0.10×X] | [★★☆] |
| **TOTAL** | **100%** | - | **[XX/100]** | - |

→ Full scoring algorithm & dimension guides: references/scoring_and_endpoints.md


Output Format Requirements

Report File Naming
  • [INDICATION]_trial_feasibility_report.md
  • Example: EGFR_L858R_NSCLC_trial_feasibility_report.md
Section Completeness

All 14 sections MUST be present (listed above).

Evidence Grading Required In

Sections 1, 4, 5, 6, 7, 10, 13 — all key claims must carry evidence grades (★★★/★★☆/★☆☆/☆☆☆).

Feasibility Score Transparency

Show calculation with raw scores, weights, and evidence sources.


Tool Quick Reference

PathPrimary Tools
PATH 1OpenTargets_get_disease_id_description_by_name, OpenTargets_get_diseases_phenotypes, ClinVar_search_variants, gnomAD_search_gene_variants
PATH 2ClinVar_get_variant_details, COSMIC_search_mutations, gnomAD_get_variant_details
PATH 3drugbank_get_drug_basic_info_by_drug_name_or_id, FDA_OrangeBook_search_drugs, FDA_get_drug_approval_history
PATH 4search_clinical_trials, PubMed_search_articles, FDA_get_drug_approval_history
PATH 5drugbank_get_pharmacology_by_drug_name_or_drugbank_id, FAERS_search_reports_by_drug_and_reaction, FAERS_count_reactions_by_drug_event
PATH 6FDA_get_drug_approval_history, PubMed_search_articles, search_clinical_trials

All tools accessed via tu.tools.<tool_name>(<params>). Use English for all query parameters.


Input Validation

This skill accepts requests that match the documented purpose of tooluniverse-clinical-trial-design and include enough context to complete the workflow safely.

Do not continue the workflow when the request is out of scope, missing a critical input, or would require unsupported assumptions. Instead respond:

tooluniverse-clinical-trial-design only handles its documented workflow. Please provide the missing required inputs or switch to a more suitable skill.

References

FileContent
references/research_paths_detail.md6 Research Path detailed execution instructions, step-by-step code, report templates, tool references
references/scoring_and_endpoints.mdFeasibility Score complete algorithm, dimension scoring criteria, endpoint selection decision tree, success criteria definitions
references/examples_and_troubleshooting.mdComplete EGFR L858R example, 5 use cases, common pitfalls, best practices, integration guide

Error Handling

  • If required inputs are missing, state exactly which fields are missing and request only the minimum additional information.
  • If the task goes outside the documented scope, stop instead of guessing or silently widening the assignment.
  • If execution fails, report the failure point, summarize what can still be completed safely, and provide a manual fallback.
  • Do not fabricate files, citations, data, search results, or execution outcomes.

© aipoch, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 13 other files (references) in scientific-skills/Protocol Design/tooluniverse-clinical-trial-design of aipoch/medical-research-skills.

  • SKILL.md
  • .env.template
  • EXAMPLES.md
  • POLISH_CHANGELOG.md
  • QUICK_START.md
  • README.md
  • Trial_Feasibility_osimertinib.md
  • UPDATE_SUMMARY.md
  • eval_report_tooluniverse-clinical-trial-design_result.json
  • python_implementation.py
  • references/examples_and_troubleshooting.md
  • references/research_paths_detail.md
  • references/scoring_and_endpoints.md
  • trial_pipeline.py

Open the folder on GitHubat commit 686e09d

Compare with similar skills

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Questions about Tooluniverse Clinical Trial Design

What does Tooluniverse Clinical Trial Design do?

Strategic clinical trial design feasibility assessment using ToolUniverse. Tooluniverse Clinical Trial Design is an agent skill from aipoch/medical-research-skills. Strategic clinical trial design feasibility assessment using ToolUniverse.

When should I use Tooluniverse Clinical Trial Design?

Tooluniverse Clinical Trial Design fits situations like: tasks that involve Experimental design; tasks that involve Clinical and healthcare research; tasks that involve Legal research.

How do I install Tooluniverse Clinical Trial Design in Claude Code?

Run `npx skills add aipoch/medical-research-skills --skill tooluniverse-clinical-trial-design -a claude-code`. Or copy the skill folder (scientific-skills/Protocol Design/tooluniverse-clinical-trial-design in aipoch/medical-research-skills) into .claude/skills/tooluniverse-clinical-trial-design in your project. Claude Code loads it when a task matches its description.

How do I install Tooluniverse Clinical Trial Design in Codex?

Run `npx skills add aipoch/medical-research-skills --skill tooluniverse-clinical-trial-design -a codex`. Or copy the skill folder (scientific-skills/Protocol Design/tooluniverse-clinical-trial-design in aipoch/medical-research-skills) into .agents/skills/tooluniverse-clinical-trial-design in your project. Codex loads it when a task matches its description.

Can I use Tooluniverse Clinical Trial Design in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add aipoch/medical-research-skills --skill tooluniverse-clinical-trial-design -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/tooluniverse-clinical-trial-design, .gemini/skills/tooluniverse-clinical-trial-design, .github/skills/tooluniverse-clinical-trial-design and .opencode/skills/tooluniverse-clinical-trial-design in your project.

What does Tooluniverse Clinical Trial Design need to run?

Going by SKILL.md and its folder, Tooluniverse Clinical Trial Design needs Python for the scripts in its folder. Our summary lists: Python 3.

Does Tooluniverse Clinical Trial Design access the network?

SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.

Is Tooluniverse Clinical Trial Design safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. Review the folder before installing.

What licence does Tooluniverse Clinical Trial Design use?

Tooluniverse Clinical Trial Design is published under the MIT licence (declared in SKILL.md). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does Tooluniverse Clinical Trial Design use?

About 2.6k tokens (SKILL.md is roughly 10k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 12k tokens, read only when the agent opens those files.

What are the alternatives to Tooluniverse Clinical Trial Design?

Skills that share tags, products or a category with Tooluniverse Clinical Trial Design: Indication Dossier (JimLiu/science-skills, 228 stars), Clinical Protocol Drafting (aws-samples/amazon-bedrock-agents-healthcare-lifesciences, 274 stars), Clinical Research (alirezarezvani/claude-skills, 28k stars) and Bio Clinical Biostatistics Adaptive Designs (GPTomics/bioSkills, 1.2k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains Tooluniverse Clinical Trial Design?

aipoch (a GitHub organization) maintains it in aipoch/medical-research-skills, which has 1,937 GitHub stars. The repository holds 578 skills in this directory. The repository was last updated on September 17, 2026.

Source: aipoch/medical-research-skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.