On Biostatistics and Clinical Trials

A colleague of mine wants to have a small program to calculate the p-values during the course of the study for a randomized, open label stud...

In a previous blog article, I discussed the “ Pediatric use and geriatric use of drug and biological products ”: For Pediatric population...

In a recent discussion about the sample size requirement for a clinical trial in a medical device field, one of my colleagues recommended a...

Recently, a question comes up when I search the clinicaltrialregistry.eu – the EU clinical trial registry website – the counterpart of cli...

Clopper-Pearson confidence interval is commonly used in calculating the exact confidence interval for binomial proportion, incidence rate,....

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...