Agent skill · research science · alirezarezvani
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.
Why this skill is useful
Adds 3 executable scripts for sample size estimation, endpoint selection, and phase gate scoring that provide structured outputs for clinical study design.
What it needs
Requires python installed locally. About 5k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.
What this skill does
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. 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 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. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/clinical-research--89971b