Clinical Trial Protocol Skill

A clinical trial protocol stands or falls on a few linked decisions: a clear objective, a design that can answer it, endpoints that measure it, eligibility that defines who's studied, and a statistical plan that can detect the effect. This skill drafts a protocol synopsis that makes those decisions explicit and internally consistent, in the structure IRBs/ethics committees and regulators expect. (For a general academic or UX study, use research-protocol.)

Safety & compliance note: this is a drafting aid for expert review, not regulatory, medical, or statistical sign-off. Real trials require qualified investigators, a statistician, and IRB/ethics and regulatory approval (e.g. GCP, ICH, local law). Do not invent efficacy/safety data; mark assumptions for the study team to set.

Working from a brief

Given "a phase II trial of drug X for condition Y", produce the full synopsis anyway — infer a defensible design, endpoints, and eligibility appropriate to the phase and condition, and clearly label every inferred choice as a draft assumption for the study team and statistician to confirm. Never fabricate prior data or effect sizes; state them as placeholders to be set.