tooluniverse-clinical-trial-design

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 grading, enrollment projections, and trial design recommendations. Use when planning Phase 1/2 trials, assessing trial feasibility, or designing biomarker-driven studies.

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

Grade	Symbol	Criteria	Examples
A	3-star	Regulatory acceptance, multiple precedents	FDA-approved endpoint in same indication
B	2-star	Clinical validation, single precedent	Phase 3 trial in related indication
C	1-star	Preclinical or exploratory	Phase 1 use, biomarker validation ongoing
D	0-star	Proposed, no validation	Novel endpoint, no precedent

3. Feasibility Score (0-100)

Weighted composite score:

• Patient Availability (30%): Population size x biomarker prevalence x 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 (additional validation), <50 LOW (de-risking required)

---

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"

---

Core Strategy: 6 Research Paths

Execute 6 parallel research dimensions. See STUDY_DESIGN_PROCEDURES.md for detailed steps per path.

Trial Design Query
|
+-- PATH 1: Patient Population Sizing
|   Disease prevalence, biomarker prevalence, geographic distribution,
|   eligibility criteria impact, enrollment projections
|
+-- PATH 2: Biomarker Prevalence & Testing
|   Mutation frequency, testing availability, turnaround time,
|   cost/reimbursement, alternative biomarkers
|
+-- PATH 3: Comparator Selection
|   Standard of care, approved comparators, historical controls,
|   placebo appropriateness, combination therapy
|
+-- PATH 4: Endpoint Selection
|   Primary endpoint precedents, FDA acceptance history,
|   measurement feasibility, surrogate vs clinical endpoints
|
+-- PATH 5: Safety Endpoints & Monitoring
|   Mechanism-based toxicity, class effects, organ-specific monitoring,
|   DLT history, safety monitoring plan
|
+-- PATH 6: Regulatory Pathway
    Regulatory precedents (505(b)(1), 505(b)(2)), breakthrough therapy,
    orphan drug, fast track, FDA guidance

---

Report Structure (14 Sections)

Create [INDICATION]_trial_feasibility_report.md with all 14 sections. See REPORT_TEMPLATE.md for full templates with fillable fields.

1. Executive Summary - Feasibility score, key findings, go/no-go recommendation
2. Disease Background - Prevalence, incidence, SOC, unmet need
3. Patient Population Analysis - Base population, biomarker selection, eligibility funnel, enrollment projections
4. Biomarker Strategy - Primary biomarker, alternatives, testing logistics
5. Endpoint Selection & Justification - Primary/secondary/exploratory endpoints, statistical considerations
6. Comparator Analysis - SOC, trial design options (single-arm vs randomized vs non-inferiority), drug sourcing
7. Safety Endpoints & Monitoring Plan - DLT definition, mechanism-based toxicities, organ monitoring, SMC
8. Study Design Recommendations - Phase, design type, schema, eligibility, treatment plan, assessment schedule
9. Enrollment & Site Strategy - Site selection, enrollment projections, recruitment strategies
10. Regulatory Pathway - FDA pathway, precedents, pre-IND meeting, IND timeline
11. Budget & Resource Considerations - Cost drivers, timeline, FTE requirements
12. Risk Assessment - Feasibility risks, scientific risks, mitigation strategies
13. Success Criteria & Go/No-Go Decision - Phase 1/2 criteria, interim analysis, feasibility scorecard
14. Recommendations & Next Steps - Final recommendation, critical path to IND, alternative designs

---

Tool Reference by Research Path

PATH 1: Patient Population Sizing

• OpenTargets_get_disease_id_description_by_name - Disease lookup
• OpenTargets_get_diseases_phenotypes - Prevalence data
• ClinVar_search_variants - Biomarker mutation frequency
• gnomAD_search_gene_variants - Population allele frequencies
• PubMed_search_articles - Epidemiology literature
• search_clinical_trials - Enrollment feasibility from past trials

PATH 2: Biomarker Prevalence & Testing

• ClinVar_get_variant_details - Variant pathogenicity
• COSMIC_search_mutations - Cancer-specific mutation frequencies
• gnomAD_get_variant_details - Population genetics
• PubMed_search_articles - CDx test performance, guidelines

PATH 3: Comparator Selection

• drugbank_get_drug_basic_info_by_drug_name_or_id - Drug info
• drugbank_get_indications_by_drug_name_or_drugbank_id - Approved indications
• drugbank_get_pharmacology_by_drug_name_or_drugbank_id - Mechanism
• FDA_OrangeBook_search_drugs - Generic availability
• FDA_get_drug_approval_history - Approval details
• search_clinical_trials - Historical control data

PATH 4: Endpoint Selection

• search_clinical_trials - Precedent trials, endpoints used
• PubMed_search_articles - FDA acceptance history, endpoint validation
• FDA_get_drug_approval_history - Approved endpoints by indication

PATH 5: Safety Endpoints & Monitoring

• drugbank_get_pharmacology_by_drug_name_or_drugbank_id - Mechanism toxicity
• FDA_get_warnings_and_cautions_by_drug_name - FDA black box warnings
• FAERS_search_reports_by_drug_and_reaction - Real-world adverse events
• FAERS_count_reactions_by_drug_event - AE frequency
• FAERS_count_death_related_by_drug - Serious outcomes
• PubMed_search_articles - DLT definitions, monitoring strategies

PATH 6: Regulatory Pathway

• FDA_get_drug_approval_history - Precedent approvals
• PubMed_search_articles - Breakthrough designations, FDA guidance
• search_clinical_trials - Regulatory precedents (accelerated approval)

---

Quick Start Example

from tooluniverse import ToolUniverse

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

# Example: EGFR+ NSCLC trial feasibility
# Step 1: Disease prevalence
disease_info = tu.tools.OpenTargets_get_disease_id_description_by_name(
    diseaseName="non-small cell lung cancer"
)
prevalence = tu.tools.OpenTargets_get_diseases_phenotypes(
    efoId=disease_info['data']['id']
)

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

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

# Step 4: Standard of care comparator
soc = tu.tools.FDA_OrangeBook_search_drugs(ingredient="osimertinib")

# Compile into feasibility report...

See WORKFLOW_DETAILS.md for the complete 6-path Python workflow and use case examples.

---

Integration with Other Skills

• tooluniverse-drug-research: Investigate mechanism, preclinical data
• tooluniverse-disease-research: Deep dive on disease biology
• tooluniverse-target-research: Validate drug target, essentiality
• tooluniverse-pharmacovigilance: Post-market safety for comparator drugs
• tooluniverse-precision-oncology: Biomarker biology, resistance mechanisms

---

Reference Files

File	Content
REPORT_TEMPLATE.md	Full 14-section report template with fillable fields
STUDY_DESIGN_PROCEDURES.md	Detailed steps for each of the 6 research paths
WORKFLOW_DETAILS.md	Complete Python example workflow and 5 use case summaries
BEST_PRACTICES.md	Best practices, common pitfalls, output format requirements
EXAMPLES.md	Additional examples
QUICK_START.md	Quick start guide

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Version Information

• Version: 1.0.0
• Last Updated: February 2026
• Compatible with: ToolUniverse 0.5+
• Focus: Phase 1/2 early clinical development