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:

Create

[INDICATION]_trial_feasibility_report.md

FIRST

Initialize with all section headers

Progressively update as data arrives

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

Version Information

Version

1.0.0

Last Updated

February 2026

Compatible with

ToolUniverse 0.5+

Focus

Phase 1/2 early clinical development