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clinical-research

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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.

research-ops/skills/clinical-research/SKILL.md

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# 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 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.
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