On Biostatistics and Clinical Trials

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 ...

For a long time, device makers have been complaining about the FDA's device approval process . I personally heard a lot of talks that th...

According to Merriam-Webster dictionary, the word " Equipoise " means a state of equilibrium. In clinical trial, the concept of ...

We keep hearing that for patient report outcome (PRO) including patient diary data, there is no query or data clarification required and the...

From this year’s Drug Information Association (DIA) annual conference in Chicago, I learned a new concept of “Adaptive Licensing”. Accordin...

Randomization and blinding are critical components of the clinical trial from the start (design) to the end. Randomized, controlled, and ...

Bland-Altman plot is a scatter plot of variable means plotted on the horizontal axis and the differences plotted on the vertical axis wh...

Last week, I had a chance to listen to a speech by Dr Scott Gottlieb. While he touched several topics in related to the health care refor...

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