On Biostatistics and Clinical Trials

Earlier this month, FDA issued its guidance " Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND an...

In the era of highly effective therapies for may diseases, clinical researchers are increasingly encountering a "good" problem in ...

When trials don’t use a traditional control — What the FDA guidance says In the usual drug-development pathway, regulators expect a trial w...

FDA created a new voucher program called " Commissioner's National Priority Voucher (CNPV) Pilot Program " to accelerate Drug ...

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...