| name | clinical-research |
| description | 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 (ISO 13485, EU MDR, FDA 510(k)/PMA/QSR), not the study design. |
| version | 2.9.0 |
| author | claude-code-skills |
| license | MIT |
| tags | ["research-ops","clinical-research","study-design","endpoint","sample-size","power","phase-gate","biostatistics"] |
| compatible_tools | ["claude-code","codex-cli","cursor","antigravity","opencode","gemini-cli"] |
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:
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.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.phase_gate_scorer.py — Scores a study plan 0-100 across recruitment feasibility, endpoint readiness, statistical power, operational complexity, and budget fit; returns GO / GO-WITH-CONDITIONS / REDESIGN / NO-GO plus the named owners who must sign.
When to use
Invoke this skill when:
- You are choosing a primary endpoint and need to defend it against surrogate-endpoint scrutiny.
- You need a defensible first sample-size estimate for a protocol synopsis.
- A study plan needs a feasibility read before a phase-gate review.
- You are pressure-testing whether the planned enrollment is achievable given the eligible population and sites.
Do NOT use this skill to: prepare a regulatory submission or clinical evaluation report (use ra-qm-team), find or position a grant (use research/grants), design a live product A/B experiment (use product-team/experiment-designer), or replace a biostatistician's final sample-size justification.
Workflow
- Draft the synopsis — Fill
assets/protocol_synopsis_template.md (objectives, design, population, endpoints, statistical plan placeholder, owners-to-sign).
- Select the endpoint — Run
endpoint_selector.py --input endpoints.json --profile {drug|device|biologic|diagnostic|digital-therapeutic}. Read the classification + surrogate flags. If >1 primary, plan multiplicity control.
