On Biostatistics and Clinical Trials

For non-inferiority clinical trials, the key issue is to pre-specify the non-inferiority margin and the non-inferiority margin has to be ba...

In the beginning (February) of this year, I attended a workshop titled “Clinical Trial Design for Alpha-1 Deficiency: A Model for Rare Dise...

Intention to treatment principle has now been an routine term in the statistical analysis for randomized, controled clinical trials. If a p...

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...