On Biostatistics and Clinical Trials

 The DMC or DSMB is now commonly used in the clinical trials, especially the late phase clinical trials. According to FDA guidance for indus...

It is pretty common these days that clinical trials (especially the late phase, adequate, and well-controlled studies) employ interim analys...

In late-phase clinical trials, an independent Data Monitoring Committee (DMC) is usually set up. If the clinical program includes multiple l...

Adaptive design has been used to drug development programs more efficient. According to FDA's guidance  Adaptive Designs for Clinical Tr...

Two weeks ago, the US Food and Drug Administration (FDA) approved aducanumab (brand name Aduhelm) as a treatment for Alzheimer's disease...

Aducanumab is an investigational compound being studied for the treatment of early Alzheimer’s disease co-developed by Biogen and Eisai. Adu...