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: