clinical-research

原文涵盖的主题

• 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

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