clinical-trial-protocol
GitHub用于起草符合监管和伦理委员会要求的临床试验方案摘要。涵盖目标、设计、人群、干预、终点、统计及安全性，强调推断内容需标记为假设供专家审核，严禁编造数据。
Trigger Scenarios
Install
npx skills add mohitagw15856/pm-claude-skills --skill clinical-trial-protocol -g -y
SKILL.md
Frontmatter
{
"name": "clinical-trial-protocol",
"description": "Draft a clinical trial protocol synopsis with the elements regulators and IRBs expect. Use when asked to write a clinical trial protocol, a study protocol synopsis, a trial design, or to structure endpoints\/eligibility\/statistics for an interventional study. Produces a structured protocol synopsis — objectives, design, population with eligibility, interventions, endpoints, statistics, and safety\/ethics — for expert review. (For non-clinical\/UX research, use research-protocol.)"
}
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.
- 7. Statistical considerations — analysis populations, the primary analysis, and a sample-size basis (with assumptions flagged for the statistician).
- 8. Safety — adverse-event definitions, monitoring/reporting, stopping rules, and any DSMB.
- 9. Ethics & conduct — informed consent, IRB/ethics approval, data integrity, and GCP adherence.
Close with assumptions to confirm and a reminder that a qualified investigator and statistician must own the final protocol.
Quality Checks
- The primary objective, primary endpoint, and primary analysis are aligned and consistent
- There is exactly one primary endpoint, clearly measurable and time-anchored
- Inclusion/exclusion criteria are explicit and operationally checkable
- Sample-size basis is stated with its assumptions flagged for the statistician
- Safety monitoring, reporting, and stopping rules are present
- Ethics/consent/IRB and GCP elements are included; no efficacy/safety data is invented
Anti-Patterns
- Do not invent prior efficacy/safety data or effect sizes — mark them as placeholders to be set
- Do not list multiple "primary" endpoints — pick one and demote the rest to secondary
- Do not let objective, endpoint, and analysis drift apart — they must answer the same question
- Do not present this as regulatory/statistical sign-off — it's a draft for expert review
- Do not omit safety monitoring and stopping rules — a protocol without them isn't approvable
Based On
Clinical research practice — objective-endpoint-analysis alignment, explicit eligibility, sample-size justification, and ICH-GCP safety/ethics structure.
Version History
- a38bc30 Current 2026-07-05 11:21
