On Biostatistics and Clinical Trials

In  a recent FDA advisory committee meeting  in November 16, 2017, we learned the first hand application of the various approaches for mult...

In recent FDA guidance ' Multiple Endpoints in Clinical Trials ' and EMA guidance ' Guideline on multiplicity issues in clinical...

The acronym is everywhere in clinical trials. Previously I mentioned that in 21st Century Cure Act , an acronym RAT was used for Regnerativ...

In previous article ' Clinical Trial Protocol Template ',  the draft template by NIH/FDA was mentioned.  NIH/FDA has now finalize...

Recently, two CAR-T (Chimeric Antigen Receptor T cell) gene therapies were approved by FDA. The first one is tisagenlecleucel manufactured ...

For a long time, drug development in rare diseases is a niche area for biotechnology companies. With the rapid advanced in genetics and ‘-o...

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...