On Biostatistics and Clinical Trials

I had previously written an article about the sub-group analysis in clinical trials. I would like to revisit this topic. The subgroup anal...

Traditionally clinical operations and drug safety / pharmacovigilence departments have elected to independently collect somewhat differen...

For typical clinical trials, the study design will include a screening period before the randomization / start of the study medication. The ...

For the past decade, there was increasing pressure on pharmaceutical companies to be transparent on the clinical trials and the clinical tri...

In last 7-8 years, there is a gradual shift from using the single-imputation method such as LOCF to MMRM (mixed model for repeated measurem...

The clinical trial data presented to us are often in longitudinal format with repeated measurements. For Continuous Endpoints in Longitudin...

Because of the FDA Transparency Initiative , the meetings, conferences, and workshops sponsored or co-sponsored by FDA are not open to the p...

I often see people cite interesting quotes in their presentation. Citing a good quote can entice the audience. I recently saw a presentatio...

Missing data is one of the critical issues in statistics and in clinical trials. Three new books about the missing data were written by the ...

FDA Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Rep...