On Biostatistics and Clinical Trials

N-of-1 clinical trial is often mentioned as one of the approaches to address the challenging issues in orphan drug development. at one point...

In a previous post, I discussed steroid tapering design clinical trials . In these trials, the primary efficacy endpoint is the reduction in...

US FDA has just endorsed the draft guideline of ICH E21 " Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials "...

In clinical trials where outcome measures violate the assumptions required for parametric statistical methods such as analysis of covariance...