Clinical Trial Protocol Skill

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.

Required Inputs

Ask for these only if they aren't already provided (else infer and label as draft):

• Intervention & condition — what's being studied, in whom, and the phase.
• Objective / question — the primary question the trial must answer.
• Comparator — placebo, standard of care, or active control; and blinding.
• Outcome of interest — how benefit (and harm) will be measured.
• Constraints — known population, setting, and any regulatory context.

Output Format

Clinical Trial Protocol Synopsis: [title]

• 1. Background & rationale — the problem, prior evidence (mark placeholders), and why this trial.
• 2. Objectives — primary and secondary, each as a precise, testable statement.
• 3. Design — phase, type (RCT, etc.), allocation/randomisation, blinding, arms, and duration.
• 4. Population — setting, and explicit inclusion and exclusion criteria.
• 5. Interventions — the intervention and comparator: dose/regimen, administration, and concomitant rules.
• 6. Endpoints — primary endpoint (one, tied to the primary objective), secondary endpoints, and how/when each is measured.