On Biostatistics and Clinical Trials

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...

one of the issues in statistics field is the adjustment for multiplicity - adjustment of alpha level for multiple tests. The multiplicity ca...

When I studied the public health many years ago, in occupational health class, the term 'person year' was pretty often used. Since t...

In order to conduct a clinical trial in the EC, the sponsor must first submit a valid request for authorisation to the Competent Authority o...

Risk Management: Risk management is the overall and continuing process of minimizing risks throughout a product's lifecycle to ...