On Biostatistics and Clinical Trials

The biotech company, Axsome Therapeutics, announced the positive results from one of their pivotal phase 3 studies (Accord study).  Axsome...

During the clinical trial, the adverse events (AEs) are collected from the signing of the informed consent to the last dose of the study dru...

For New Drug Application (NDA) and Biological License Application (BLA), the usual process is to submit the entire package with different mo...

Today, the FDA finalized its guidance for industry " Multiple Endpoints in Clinical Trials ". The draft version of this guidance w...

Several years ago, I posted an article " Should hypothesis tests be performed and p-values be provided for safety variables in efficacy...

For professionals who are working in drug development areas, the term PDUFA should be a very familiar term. As a matter of fact, FDA's a...

For clinical trials, the safety analyses are mainly based on the analyses of the adverse events including serious adverse events. The advers...

For any drug development program, the early and sometimes frequent communications are critical. However, the formal communications between t...

This past week, the biotech company BrainStorm announced the decision to submit a BLA to the FDA for NurOwn® (a stem cell treatment) for th...

In a recent publication (Benza et al " Contemporary Risk Scores Predict Clinical Worsening in Pulmonary Arterial Hypertension - An Anal...

In clinical trials, the samples are often collected and sent to the central laboratory or specialty laboratory for measuring certain paramet...

RCTs (randomized, controlled clinical trials) are still the golden standard in clinical research. In RCTs, the most common control group is ...

CRO (Contract Research Organization or Clinical Research Organization) A CRO is a company that provides clinical trial management services f...

If the death event is an efficacy endpoint in the study, should the death event still be reported as AE/SAE?  If the death (or mortality) is...