On Biostatistics and Clinical Trials

In clinical trials, subject’s age is a critical demographic variable that needs to be collected. Age may be used in checking the inclusion...

For clinical laboratory data analyses, statistical tabulations are typically generated to list the number of subjects in each treatment gr...

FDA recently issued its guidance " Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease ". The guidanc...

Recently, a new drug approval pathway proposed by FDA has drawn attentions to many pharmaceutical/biotechnology companies. Last year, The ...

Typically, in medical journals, we don’t like to include a lot of formula or mathematical expressions in articles. However I recently read...

Free Seminar on Current Topics in Bioethics By Sheila Mikhail, founder of Life Sciences Law (LSL) The field of bioethics merges variou...

Generally not. The new IND safety reporting regulation and associated guidance state that study endpoints that are Serious Adverse Events...

For interventional clinical trials, there are clear regulatory guidelines to govern the development of the study protocol, the conduct o...

FDA recently issued its new guidance to industry “ EnrichmentStrategies for Clinical Trials to Support Approval of Human Drugs andBiologic...

In all clinical trials, it is important to collect the adverse event information accurately. It is very common to collect the adverse events...