clinical-research
Use when designing a prospective clinical study: choosing primary and secondary endpoints, estimating sample size and power, or scoring feasibility before submission. Runs endpoint_selector.py, sample_size_estimator.py and phase_gate_scorer.py; outputs are estimates for a biostatistician to confirm.
Target: Learning & research. Automatically collected · unverified.
Excerpt from the author’s documentation
Extracted from a fixed version of SKILL.md in its original language. This is the author’s documentation; installation, compatibility and runtime results have not been verified by this site.
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Topics in the source
- clinical-research
- Purpose
- When to use
- Workflow
- Scripts
- Onboarding & customization
- Optimize with autoresearch (opt-in)
- References
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. 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. samplesizeestimator.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. endpointselector.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. phasegatescorer.py — Scores a study plan 0-100 across recruitment feasibility, endpoint readiness, statistical power, operational complex
This is an excerpt. Refer to the complete source and its current requirements.
- Source repository
- alirezarezvani/claude-skills
- Source file
- research-ops/skills/clinical-research/SKILL.md
- Fixed revision
- 8f082544116fc0d014188e521ca40304cdfc86b0
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- Only the author’s Skill metadata is included. Read the full instructions to check dependencies, licensing and conditions of use.
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Author: alirezarezvani/claude-skills · original repository metadata. Documentation review: Not reviewed. Last source check: 2026-11-09T14:01:47.537Z.
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