On Biostatistics and Clinical Trials

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. "...

Local IRB seems to become very picky nowadays. Recently, one of the local IRBs in New York insists that we can not collect patient's dat...

Even thoug this is a joke, I find sometimes it is very true. A manager wanted to hire someone to work in her department and she had applicat...

Thanks for my colleagure who point out my mistake in calculating the sample size adjusting for the drop out rate. According to the sample si...

I am surprised to know that there is a SAS procedure for CDISC. Is this procedure really working? http://support.sas.com/rnd/base/topics/sxl...

Question: I have 3 samples which were each measured for protein content of IgG, and several other proteins (in mgs/ml). As you can see, all ...

If a country implements a family planning policy as below: If the first child is a boy, no second child is allowed. If the first child is a ...

In a recent meeting with some investigators, we discussed the protocol for a phase II clinical trial. When I ask whether or not if we need t...