On Biostatistics and Clinical Trials

"Overtreated", "Overdiagnosed", and "Overdosed",... these are the terms I have used in one of seminars several...

Unless a clinical trial is designed for the pregnancy women, the typical clinical trial will exclude the females with pregnancy and lactatin...

I recently participated in a project to compare two different ways to do the meta analysis: the traditional way to pool the database directl...

According the ICH guidance E10 (CHOICE OF CONTROL GROUP AND RELATED ISSUES IN CLINICAL TRIALS), "A placebo is a "dummy" trea...

I am not sure how many people really know these abbreviations: DOE, IQ, OQ, PQ, PV. These are the terms used in the validation of a software...

In a May article, I discussed several practical procedures for multiple testing issue . One of the procedures is Hockberg's procedure. T...

Poisson regression is a method to model the frequency of event counts or the event rate, such as the number of adverse events of a certain t...

Some terms often used in epidemiology fields are actually pretty commonly used in clinical trials. At least for me, I first learned these te...

I had a chance to listen to a seminar by Richard De Veaux in an event organized by SAS JMP for data mining. Dick is really an excellent sp...

Dose-escalation is a type of clinical trial design in which the amount of the drug is increased with each cohort that is added. Each cohort ...

Odds Ratio (OR) and Relative Risk (RR) are two ratios often used in the epidemiology studies and the clinical trials. They are related, but ...

Interactive Voice Response (IVR) is an interactive technology that allows a computer to detect voice and keypad inputs. Its use in clinical...

The first time when I used the term "Spaghetti" was for one of the pharmacokinetic studies where I would like to see the time-conc...

Williams Design is a special case of orthogonal latin squares design. It is a high-crossover design and typically used in Phase I studies. D...

In clinical development, filing of IND (Investigational New Drug) is an important milestone. FDA is required by the Modernization Act to res...

Double dummy is a technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made ...

Sometimes, the only data we have is the summary data (mean, standard deviation, # of subjects). Can we use the summary data (instead of the ...

For a multiple-dose regimen, the amount of drug in the body is said to have reached a steady state level if the amount or average concentrat...

A surrogate endpoint is intended to substitute for a clinical endpoint. A surrogate endpoint is expected to predict clinical benefit (or ha...

Medical imaging has now been a critical part in clinical trials. It can be used in many aspects of clinical trial process: 1) Disease dia...