When to Trigger
Activate this skill when the user mentions:
- Clinical trial design, RCT, randomized controlled trial
- Sample size calculation, power analysis for trials
- CONSORT, STROBE, SPIRIT guidelines
- Phase I, II, III, IV trials
- Primary/secondary endpoints, composite endpoints
- Interim analysis, adaptive trial design, futility
- Blinding, randomization, allocation concealment
- Intention-to-treat (ITT), per-protocol analysis
Step-by-Step Methodology
- Define the research question - Specify PICO (Population, Intervention, Comparator, Outcome). Determine if superiority, non-inferiority, or equivalence design is appropriate.
- Select trial phase and design - Choose phase (I: safety/dose, II: efficacy signal, III: confirmatory, IV: post-market). Consider parallel, crossover, factorial, or adaptive designs.
- Primary endpoint selection - Define primary outcome (must be clinically meaningful). Specify measurement timing and minimal clinically important difference (MCID).