clinical-trial-design-guide
Installation
SKILL.md
Clinical Trial Design Guide
A skill for designing and analyzing clinical trials, covering study design selection, sample size calculation, randomization methods, interim analysis, survival endpoints, and regulatory considerations. Essential for pharmaceutical researchers, biostatisticians, and clinical scientists.
Clinical Trial Phases
Phase Overview
| Phase | Objective | Typical N | Duration | Primary Endpoints |
|---|---|---|---|---|
| Phase I | Safety, dose-finding | 20-80 | Months | MTD, DLT, PK profile |
| Phase II | Efficacy signal, dosing | 100-300 | 1-2 years | Response rate, biomarker |
| Phase III | Confirmatory efficacy | 300-3,000+ | 2-4 years | OS, PFS, clinical outcome |
| Phase IV | Post-marketing surveillance | 1,000+ | Ongoing | Safety, real-world effectiveness |