On Biostatistics and Clinical Trials

In biological field, it is pretty common to collect and analyze the adverse events that are temporally associated with an infusion. For exam...

Typically, the physicians will listen to statisticians for statistical analysis approaches. In some cases, the physicians can be very smart ...

Four rules to adapt by: Allocation rule: how subjects will be allocated to the avaialble arms Sampling rule: how many subjects will be sam...

A recent article by Mr Getz in Applied Clinical Trials elaborated the heavy burden of protocol design in modern clinical trials. The clinica...

My fellow colleague expressed his frustration about exlaining a statistical concept to our clinical operation colleagues. I fully undertood ...

Rule of three states that consider a Bernoulli random variable with unknown probability p, if in n independent trials no events occur, a qui...

In regulatory setting, can we showing the treatment difference by comparing the slopes between two treatment groups? In a COPD study (e.g., ...

In bioavailability and bioequivalence studies, the pharmacokinetic parameters ( AUC , Cmax ) are often assumed to follow the log normal d...

I recently find the book edited by Parexel is extremely useful. Good Clinical Practice: A Question & Answer Reference Guide Edited by Ma...

The intent to treat (or intention to treat) principle was invented by the statistician about 30 years ago. It took a while for the clinical ...

We have been using the following formula in calculating the length of the study drug exposure in many studies: # of days of drug exposure = ...

In the late 18th century, King Gustav III of Sweden decided that coffee was poison and ordered a clinical trial. The King condemned a convic...

Clinical equipoise provides the ethical basis for conduct of randomized clinical trials. This principal states that a clinical trial is acce...

Traditionally, we have been talking about the phase I to phase IV clinical trials in drug development. We start from the small trials in hea...

I have heard the term "evidence-based medicine", "socialized medicine", "individulized medicine", now there is...

I cite the following statement about the interim analysis due to two reasons: 1. Hazard ratio sometimes is very tricky. When hazard ratio is...

A standard category of frequency for adverse drug reactions are provided in "Guidelines for Preparing Core Clinical-Safety Information ...

When reporting the adverse events in core safety information (CSI), sometimes, the corporate faces a dilemma. On the one hand, due to the le...

I recently read a book by T.J. Cleophas titled "Statistics Applied to Clinical Trials". It is interesting that the author em phase...

Question: "A Sponsor PM would like to know how many subjects can be enrolled at their largest-enrolling site before it begins to skew t...