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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.
Passed 8 of 14 test cases with the skill, and 7 of 14 without it.
and 4 more in the full report
5 fixed7 passed either way6 still failing4 broke
Tokens, turns and time describe resource use, not a dollar price.
One of 5 test cases the skill fixed. Same model, same prompt, with and without the skill.
When performing an end-to-end clinical development evaluation for an indication, what is the mandatory first step before presenting data to the user, and what file format should be created to progressively aggregate data?
| Checked | Without skill | With skill |
|---|---|---|
| Specifies creating a dedicated report file with all section headers initialized prior to presenting final results. | Missed | Passed |
| Names the report structure file formatted as `[INDICATION]_trial_feasibility_report.md`. | Missed | Passed |
The instructions your model reads when the skill loads.
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.
Trial design starts with the question, not the methods. Answer these four questions before running any tools — they determine everything else:
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.
DO NOT show tool outputs to user. Instead:
[INDICATION]_trial_feasibility_report.md FIRST| 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 |
Weighted composite score:
test cases passed, vs 7 / 14 without
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