Sample Size Re-estimation During Ongoing Trials: Statistical Strategies and Regulatory Insights
Sample Size Re-estimation During Ongoing Trials: Statistical Strategies and Regulatory Insights Sample Size Re-estimation During Ongoing Trials: Statistical Strategies and Regulatory Insights Clinical trials often begin with carefully calculated sample sizes, but real-world variability, unexpected effect sizes, or changing variance can make mid-course corrections necessary. Sample size re-estimation (SSR) allows ongoing trials to remain sufficiently…