On Biostatistics and Clinical Trials

Two years ago, I had a post discussing " Dose Cohort Expansion Study - A Never Ending Phase I Study Design ". Last month, FDA offi...

When we perform the statistical test to compare the difference between two treatment groups, we usually construct a test statistic, calcula...

Every clinical trial should have a protocol and the protocol needs to include the inclusion/exclusio criteria to define the study population...

When planning for clinical trials, sample size calculation is a two-step or three-step process. For clinical trials with continuous variable...

In clinical trials, reporting of adverse events is critical to ensure the safety of participants. When an adverse event is reported, it is ...

For all adverse events including serious adverse events in clinical trials, severity (or intensity) should be assessed and recorded. AE se...

While the randomized, control clinical trial has become and remains to be the golden standard in drug development, we also see the increas...

As I was recently preparing a poster for ATS Internal Conference , I was told that the plots I provided were not in high quality. When placi...

Stratified randomization is very common in randomized, controlled clinical trials. The usage of stratified randomization has been discuss...

This month, we saw FDA issued five guidance documents for drug development in five different neurological conditions/diseases (Alzheimer’s...