clinical-research
Use when designing a prospective clinical study before submission — selecting and classifying endpoints (primary / key-secondary / exploratory, with surrogate-endpoint flagging), estimating sample size and power for two-arm designs (means / proportions / survival), or scoring a study plan for feasibility and a GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO phase-gate decision. Every output is an ESTIMATE plus a named human owner (clinician / biostatistician / regulatory owner) — never clinical fact, never a finished protocol. Distinct from ra-qm-team, which handles the regulatory/QM submission (IS
Profile →npx skills add alirezarezvani/claude-skills --skill clinical-research --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# clinical-research Prospective clinical study DESIGN: endpoints, sample size / power, and phase-gate feasibility. Every output is an **estimate with stated assumptions** routed to a **named human owner**. This skill never gives clinical advice as fact and never substitutes for a biostatistician or regulatory affairs. ## Purpose R&D clinical teams, medical monitors, and biostatistics functions live at the moment between *we-have-a-hypothesis* and *we-have-a-protocol-ready-for-submission*. This skill structures three of the hardest design decisions: Three deterministic tools: 1. `sample_size_estimator.py` — Closed-form power / sample-size for two-arm **means** (Cohen's d), **proportions** (normal approximation), and **survival** (Schoenfeld events). Inflates for dropout. Prints an "ESTIMATE — confirm with a biostatistician" banner. 2. `endpoint_selector.py` — Scores candidate endpoints across 5 weighted dimensions (clinical relevance, measurability, regulatory acceptance, sensitivity-to-change, burden) and classifies each as **PRIMARY / KEY-SECONDARY / EXPLORATORY**. Penalizes unvalidated surrogate endpoints. 3. `phase_gate_scorer.py` — Scores a study plan 0-100 across recruitment f
- Purpose
- When to use
- Workflow
- Scripts
- Onboarding & customization
- Optimize with autoresearch (opt-in)
- References
- Assumptions
- Anti-patterns
- Distinct from
- Quick examples
- Forcing-question library (Matt Pocock grill discipline)
python3 scripts/onboard.py # interactive (also: --defaults, --set key=value, --reset) python3 scripts/onboard.py --show # see the questions + current effective config python3 scripts/sample_size_estimator.py --sample python3 scripts/sample_size_estimator.py --design proportions --p1 0.30 --p2 0.45 --dropout 0.15 python3 scripts/endpoint_selector.py --sample python3 scripts/phase_gate_scorer.py --sample --output json
What does the clinical-research skill do?
Use when designing a prospective clinical study before submission — selecting and classifying endpoints (primary / key-secondary / exploratory, with surrogate-endpoint flagging), estimating sample size and power for two-arm designs (means / proportions / survival), or scoring a study plan for feasibility and a GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO phase-gate decision. Every output is an ESTIMATE plus a named human owner (clinician / biostatistician / regulatory owner) — never clinical fact, never a finished protocol. Distinct from ra-qm-team, which handles the regulatory/QM submission (IS
How do I install it?
Run `npx skills add alirezarezvani/claude-skills --skill clinical-research --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From alirezarezvani/claude-skills, a repository with 23,791 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.