On Biostatistics and Clinical Trials

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...

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

In reading the book "Introduction to applied pharmacoeconomics" by Vogenberg FR, I found the following statement very true. "...