On Biostatistics and Clinical Trials

 The DMC or DSMB is now commonly used in the clinical trials, especially the late phase clinical trials. According to FDA guidance for indus...

During the clinical trial, the adverse events (AEs) are collected from the signing of the informed consent to the last dose of the study dru...

Several years ago, I posted an article " Should hypothesis tests be performed and p-values be provided for safety variables in efficacy...

For clinical trials, the safety analyses are mainly based on the analyses of the adverse events including serious adverse events. The advers...

In clinical trials, there are usually different committees established to ensure the study protocol is executable, to ensure the integrity o...

According to Wiley Encyclopedia of Clinical Trials, the maximum tolerable dose  (MTD) is defined as:  The “Maximum Tolerable Dose” (MTD), a...

Many date variables are collected in the clinical trial database. The date variables include date of birth, date of disease diagnosis, date ...

In our daily life, benefit-risk evaluation is something we always do whether we realize it or not. Benefit-risk evaluation is especially cri...