On Biostatistics and Clinical Trials

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...

Biosimilars or Follow-on biologics are terms used to describe officially approved new versions of innovator biopharmaceutical products, foll...

I guess that the iDMC (stands for independent Data Monitoring Committee) has been used for a while, however, I first time heard the terms iS...

As stated in Demets ' paper "Liability issues for data monitoring committee members" (Clinical Trials 2004; 1: 525–531): In ra...

When we perform the correlation analysis, we typically calculate the correlation coefficient and then test if this correlation coefficient i...

The Wall Street Journal (2/19, Wang) reports, "Most testing for the US drug industry's late-stage human trials is now done at site...

New York Times had a series of articles to explore medical treatments used despite scant proof they work and examining steps toward medicine...

Cronbach's Alpha is a tool for assessing the reliability of scales (for example a quality of life instrument). Cronbach's alpha can ...

Blood plasma, or plasma, is prepared by obtaining a sample of blood and removing the blood cells. The red blood cells and white blood cells ...

DMC (Data Monitoring Committee) vs. DSMB (Data Safety Monitoring Board) are the same thing. The term DMC is used more now because it is the ...

Everybody with basic statistical knowledge should understand the differences between the standard deviation (SD) and the standard error of m...