On Biostatistics and Clinical Trials

A friend of mine asked me about the difference between ‘personalized medicine’ and ‘precision medicine’. Just a couple of years ago, the te...

Recently, NPR had a discussion about the influence of Placebo effect on consumer product purchases .   While the concept of the placebo ef...

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question. In Phase...

Great news to new SAS learners! SAS have made their introductory e-learning courses available to everyone at no cost. Don’t miss this chanc...

In the recent issue of NEJM.org, Karl Swedberg, M.D., Ph.D et al wrote an article “ Challenges to Data Monitoring Committees When Regulator...

Duchenne muscular dystrophy (DMD) is an inherited disorder that involves   muscle weakness , which quickly gets worse. Duchenne muscular dy...

When submitting the NDA (new drug application) or BLA (biological license application) to FDA, as part of the CTD (common technical documen...

For any clinical trial, the study protocol is the most critical document and is the blueprint of the entire study. There are clinical studi...

Last month, FDA released its final guidance " Guidance for Industry: Determining the Extent of Safety Data Collection Needed in Late-St...