On Biostatistics and Clinical Trials

Recently, I found some materials related to a lawsuit against the Nuvelo Pharmaceuticals – a company who used to develop a clot-busting prod...

When we perform the logistic regression, sometimes, we may run into an issue so called ‘complete or quasi-complete separation of data points...

I recently noticed a new approach so called 'Rasch Analysis' when I worked on a paper in dealing with the MCID (minimal clinically i...

During the holiday season, it is very typical for a corporate to hold a party for its employees. During the party, one activity is to win th...

For a long time, we have been using SAS GPLOT for creating graphs. Beginning from SAS version 9.2, there is a new procedure called SAS SGLPO...

Subject Diary, often called Patient Diary, is a tool used in the clinical trials. There could be three types of diary technologies. The trad...

In statistical / biostatistical analysis, it is pretty common to apply the data transformation technique. The reason is to achieve the norma...

Paired data contains values which fall normally into pairs and can therefore be expected to vary more between pairs than within pairs. The ...

In the United States, every marketed drug or biological product needs to have its product label or package insert. The product label contain...

GUIDELINE FOR GOOD CLINICAL PRACTICE GxP is now used to represent a collection of quality guidelines in clinical trial. The titles of the...

When I started my career in biostatistics, I joined the American Statistical Association (ASA) and attended its annual meeting ( Joint Stat...

When I see a news headline about "what is the most popular course in the Harvard University?", my curiosity drives me to find out ...

"Overtreated", "Overdiagnosed", and "Overdosed",... these are the terms I have used in one of seminars several...

Unless a clinical trial is designed for the pregnancy women, the typical clinical trial will exclude the females with pregnancy and lactatin...

I recently participated in a project to compare two different ways to do the meta analysis: the traditional way to pool the database directl...

According the ICH guidance E10 (CHOICE OF CONTROL GROUP AND RELATED ISSUES IN CLINICAL TRIALS), "A placebo is a "dummy" trea...

I am not sure how many people really know these abbreviations: DOE, IQ, OQ, PQ, PV. These are the terms used in the validation of a software...

In a May article, I discussed several practical procedures for multiple testing issue . One of the procedures is Hockberg's procedure. T...

Poisson regression is a method to model the frequency of event counts or the event rate, such as the number of adverse events of a certain t...

Some terms often used in epidemiology fields are actually pretty commonly used in clinical trials. At least for me, I first learned these te...