tooluniverse-clinical-trial-design

SKILL.md

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:

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.

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.

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).

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.