Healthcare Economist November 19, 2022
Jason Shafrin

At first glance, one may think the answer is no. Randomization should insure that baseline characteristics are balanced across trial arms. In practice, however, sometimes baseline characteristics due differ somewhat by trial arm simply by chance, especially in smaller randomized controlled trials (RCTs). A JAMA Guide to Statistics and Methods by Holmberg et al. 2022 provides justification for why you would want to adjust for baseline characteristics in many cases.

…adjusting for baseline characteristics in the analysis of RCTs is advised by both the European Medicines Agency and the US Food and Drug Administration because it may improve statistical efficiency, enhancing the ability to draw a reliable conclusion from the available dat

It is most important to adjust...

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