On Biostatistics and Clinical Trials

FDA has recently issued a series of draft guidance on “providing regulatory submission in electronic format”. The most recent one is about “...

A colleague of mine asked me to explain the concept of “futility analysis” using plain languages. The question is triggered by the recent n...

Here is a question posted on the web about the interpretation of odds ratios that are less than 1. "I know that OR estimates= 1 mean th...

For bioequivalence studies, it is often for us to show the average bioequivalence by declaring the bioequivalence if the 90% confidence int...

In clinical trials, death event may occur. According to CDISC CDASH standards , death should not be recorded as an adverse event (AE) or s...

Professionals who are new to the clinical trial field are often confused with the concept of ' Serious Adverse Events (SAEs)' and ...

In clinical trials, the serious adverse event reporting is critical to the safety assessment and to fulfill the regulatory requirements. The...

Last time, I discussed the outliers and a simple approach of Dixon’s Q test for detecting a single outlier . When there are multiple outlier...

In clinical trials, we deal with the outlier issue differently from other fields. During the clinical trial, for the suspected ‘outlier...

Xigris , also called Drotrecogin Alfa (Activated) or Protein C, was the only approved drug for severe sepsis indication and it was withdraw...

Not sure where the origin is. It is circulated quite a bit.  Best friends graduated from medical school at the same time and decided that, ...

The traditional way to do the clinical trial data management is to use the paper based case report forms (CRFs). The blank paper CRFs are di...

In many clinical trials, the outcome is binomial and a 2 x 2 table can be constructed. The analysis can be based on the difference in two ...

In industry, the current monitoring practice relies on ‘ on-site monitoring ’ and 100% source data verification (on all data fields). This ...

In my previous article, I discussed the odds ratio and risk ratio (or relative risk ratio) . In clinical trials with binary outcome, both ...