Assumption-driven calculations
Sample size derived from documented effect size and variability assumptions, developed in step with study design decisions rather than after the fact.
What's included
What goes into the calculation
- Effect size, variability, and clinically meaningful difference assumptions documented and sourced
- Power and sample size calculated for the primary endpoint, with sensitivity analyses across key assumptions
- Dropout, non-adherence, and multiplicity adjustments built into the enrollment target
- Adaptive or group-sequential sample size re-estimation methodology, where applicable
- Protocol- and SAP-ready justification text, written for direct inclusion rather than paraphrasing
Statistical justification
Sample size sections written for direct inclusion in the protocol and statistical analysis plan, with methodology that withstands reviewer questions.