On Biostatistics and Clinical Trials

Last week at the 4th Duke-Industry Statistics Workshop , I participated in a session " Innovative clinical trial designs " organiz...

In my previous post " Constructing stopping rule for safety monitoring ", I discussed the use of exact binomial confidence interv...

In the most recent issue of New England Journal of Medicine, Stone et al published the results from " Trial of Tocilizumab in Giant-Ce...

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...