On Biostatistics and Clinical Trials

Working in industry setting (versus academic), we all understand that it is critical for us to be familiar with the Standard Operating P...

If you see the term “I-spy”, you would typically think something related to movie, kids game or TV series. Recently, I-spy has been linked t...

Recent discussions with my friends in China surprised me a little bit. They are way ahead in applying the advanced technology in public heal...

This Wednesday, I had a chance to attend “University of Pennsylvania Annual Conference on Statistical Issues in Clinical Trials”. The topi...

In drug development, it is necessary to understand the pharmacokinetics profiles (or time concentration profiles) of the experimental drug a...

The SF-36 is a multi-purpose, short-form health survey with 36 questions. SF-36 is one of the most popular instruments for generic health su...

I am very surprised to see how a simple concept of ‘incidence rate’ can be wrongly calculated in documents  submitted to regulatory agencies...

Pooling the study center for statistical analysis purpose is rather an old issue. However, we can still see the discussion o f study center ...

Nowadays, the clinical study protocols are becoming more and more complicated and require more and more blood sample draws for various purpo...

In clinical trial, one critical task is to ensure that the data collected or data entered into the system / database is valid, correct, and ...

When we move toward the clinical studies using electronic data capture, the ‘source data’ or ‘source document’ has been an issue. Unlike the...

Have you noticed the changes in the design of FDA website ( http://www.fda.gov/ ) recently? Last August, I mentioned the FDA's initiati...

In clinical trial and medical research, we often have a situation where two different measures/assessments are performed on the same sample,...

In statistics, bootstrapping is a resampling technique used to obtain estimates of summary statistics. In clinical trials, bootstrapping te...