On Biostatistics and Clinical Trials

In planning the clinical program for drug approval, in addition to the efficacy assessment, the adequate size of the safety database is usu...

“Biomarkers” and “Surrogate endpoints” are closely related, a lthough a biomarker can serve as a surrogate endpoint, the terms of biomarker...

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 ...