Portfolio of CMR Opportunities in Clinical Research-Topic Video

Video Transcription

Video Summary

The speaker gives a high-level overview of sample size calculation for clinical trials. They explain that sample size depends on the research question, study design, endpoints, and statistical test, and that key inputs include significance level (alpha), power (1−beta), expected effect size, and variability/standard deviation. Lower alpha, higher power, smaller effect sizes, and greater variability all increase required sample size. For survival studies, the number of events matters. Two examples are given: a continuous outcome (blood pressure) and a binary outcome (hospitalization rate), with calculations shown using formulas and R software. The speaker also notes that dropout/loss to follow-up should be added to the final sample size. Overall, the main message is that sample size planning is essential for adequate power, and complex designs usually require a statistician.

Keywords

sample size calculation

clinical trials

statistical power

effect size

dropout adjustment