On Biostatistics and Clinical Trials

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 ...

Effect size (ES) is a name given to a family of indices that measure the magnitude of a treatment effect. Unlike significance tests, these i...

If you work with SAS, you probably heard and used the term 'least squares means' very often. Least squares means (LS Means) are actu...

In a cost-effectiveness assessment report, a detail descriptions were provided for the approaches in choosing the clinical trial data for me...

Stratified randomization refers to the situation in which strata are constructed based on values of prognostic variables or baseline covaria...

Typically, the regulatory authority requires two pivotal studied to demonstrate the efficacy. If the results from two studies show the confl...

The paragraphs below are from the following website: http://firstclinical.com/journal/2008/0806_GCP35.pdf Some protocols instruct investigat...

There is some debate and inconsistencies regarding the definition of Adverse Drug Reactions. If you call it an adverse event, you may not ha...

I used Revman program to do my meta analysis and generated the nice Forest plot two years ago. It worked for me very well at that time. Revm...