On Biostatistics and Clinical Trials

Converting SAS data sets to Excel Book  In clinical trials, the database may be stored in SAS data set format. Sometimes, there is a need ...

For a non-inferiority trial, after the non-inferiority is shown, one will typically try to show the non-inferiority. People may argue that ...

To be a good statistician, mastering the programming (SAS, SPSS, R, ...) is very important. This is especially true for statisticians who ar...

When performing the data analysis, sometimes the data is skewed and not normal-distributed, and the data transformation is needed. W...

“To cope with situations where data collection is interrupted before the predetermined last evaluation timepoint, one widely used sing...

In Clinical Pharmacology, inferential statistics is performed to show the bioequivalence in terms of the Area Under the Curve (AUC) and ...

In my previous article " Should the design and conduct of clinical trials be simplified? ", I discussed several FDA guidance that...

As mentioned in one of FDA’s guidance, “in the past two decades, the number and complexity of clinical trials have grown dramatically. These...

FDA has recently issued a series of draft guidance on “providing regulatory submission in electronic format”.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...