Welcome

Thank you for stopping by and welcome to my blog! I'm truly glad you're here!

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Randomization Is Not Just About Balance

Randomization in clinical trials is often perceived as a tool to “balance covariates” between treatment groups. While this view is correct, it is incomplete and somewhat misleading. Randomization is not primarily about balance, but rather, it provides a design-based foundation for valid causal inference. Where Does the Probability Come From? In a randomized clinical trial (RCT), probability is not introduced through modeling assumptions such as normality, nor is it fundamenta

May 23 min read

What Defines a Good Clinical Statistician

I recently attended a leadership training session where a colleague shared an experience involving a physician on a Data Monitoring Committee (DMC) who questioned the qualifications of the committee statistician. The physician was concerned because the statistician often remained quiet during routine DMC meetings, which typically focus on safety issues. My colleague, however, was confident that the statistician was fully qualified for the role. This raises an interesting ques

Nov 14, 20252 min read

Don't Compromise Control Groups

Randomized, double-blind, controlled trials (RCTs) are widely considered the gold standard for modern intervention-based clinical...

May 24, 20252 min read

Understanding FDA Recommendations for Covariate Adjustment in Randomized Clinical Trials

In May 2023, the US Food and Drug Administration (FDA) issued final guidance on adjusting for covariates in randomized clinical trials (RCTs), titled "Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products". This guidance provides both general considerations and specific recommendations for covariate adjustment in linear and nonlinear models. It is a valuable resource for industry statisticians, offering insights into the various statistical

Aug 25, 20245 min read

Be a free thinker and don't accept everything you hear as truth. Be critical and evaluate what you believe in.

― Aristotle

Hi, I’m Andrew

I believe that statisticians bear a unique responsibility in a world shaped by randomness and uncertainty. As a clinical statistician, I consider it essential to take ownership of critical thinking and to exercise independent statistical judgment throughout the drug development process. This belief is what drives this blog. I'm committed to delivering content that is interesting and, hopefully, intellectually engaging and thought-provoking.