FDA revises and expands draft guidance on adjusting for covariates in RCTs
The FDA on Thursday revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials (RCTs).
Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft has been transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.