On Biostatistics and Clinical Trials

When planning for a clinical trial, an important step is to estimate the sample size (the of patients needed to detect the treatment differ...

Previously, I discussed the protocol template for clinical trials . This week, FDA/NIH and TransCelerate simultaneously released the final ...

I recently re-read the book “ What Money Can't Buy: The Moral Limits of Markets ” by Michael J. Sandel . The example used in the book a...

Last week, I attended the 10th Annual Conference on Statistical Issues in Clinical Trials held in the camps of the University of Pennsylvani...

It is sometimes important to know how likely a study is to detect a relatively uncommon event, particularly if that event is severe, such a...

In the United States, the government can promote or incentivize the drug development in certain areas through its policies. In FDA, there a...

In randomized controlled clinical trials, we usually need to consider if there are any prognostic factors that may have influence on the pr...

In clinical trials, the most popular randomization approach is probably the randomized block design. With a  randomized block design, study...

In one of my previous posts, I discussed " Protocol Deviation versus Protocol Violation and its Classifications (minor, major, critica...