Strategic clinical trial design feasibility assessment. Analyzes 6 dimensions (endpoint, population, comparator, effect size, duration, regulatory pathway) using precedent trials and FDA guidance. Produces enrollment projections, endpoint recommendations, and approval-pathway analysis. Use for trial

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. LOOK UP DON'T GUESS : Never assume what the standard of care is for an indication — look it up with DrugBank and FDA tools. Never assume an endpoint is FDA accepted — verify with search clinical trials precedents and OpenFDA get approval history . Never estimate prevalence from memory — use OpenTargets, gnomAD, or COSMIC. 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. 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 by target ensembl Prevalence data ClinVar search variants Biomarker mutation frequency gnomad search 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 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 drug Generic availability OpenFDA get 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 OpenFDA get 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 OpenFDA get approval history Precedent approvals PubMed search articles Breakthrough designations, FDA guidance search clinical trials Regulatory precedents (accelerated approval) Quick Start Example 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 Programmatic Access (Beyond Tools) When ToolUniverse tools return limited trial metadata, use the ClinicalTrials.gov v2 API directly: See tooluniverse data wrangling skill for pagination, error handling, and bulk download patterns. 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

tooluniverse-clinical-trial-design