Author | Elizabeth B. Andrews, PhD, MPH


The REMS Publication Paradox

July 14, 2009

ByElizabeth B. Andrews, PhD, MPH|James A. Kaye, MD, DrPH|Carla Van Bennekom, MPH

The introduction of mandatory risk evaluation and mitigation strategy (REMS) programs, in which patients must participate in order to receive a new therapy, provides an opportunity to examine an issue affecting ethical oversight and publication of scientific study results.