On Biostatistics and Clinical Trials

Each year, the FDA's Division of Pediatrics and Maternal Health in collaboration with the University of Maryland CERSI organized an an...

These two topics seem to be irrelevant at all, but have one thing in common: changing the subjects when the decision is questioned. For the ...

Every Saturday, my favorite radio show is " Wait Wait... Don't Tell Me! | WUNC ". In yesterday's episode, the host made fu...

In 2019, there was a public debate about the use or misuse of statistical significance and p-values. I wrote a post about it " Retire ...

In previous posts, we discussed the " Randomized Withdrawal Design and Randomized Discontinuation Trial " and " Randomized Wi...

FDA had their annual conference “ FDA Regulatory Education for Industry (REdI) ” last week. The REdI conference features three medical produ...

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 ...

I recently listened to a podcast from NPR's planet money " Blood Money ". It discussed why only the U.S. and a few other coun...

In early-phase clinical trials, determining the dose range and therapeutic window is critical. The purpose of the early-phase studies may ju...

Two weeks ago, the US Food and Drug Administration (FDA) approved aducanumab (brand name Aduhelm) as a treatment for Alzheimer's disease...