Strategies for postmarketing surveillance of drugs and devices in patients with ESRD undergoing dialysis

Moshe Vardi, Robert W. Yeh, Charles A. Herzog, Wolfgang C. Winkelmayer, Soko Setoguchi Iwata, David M. Charytan

Publication Date: 12/06/2013

The lack of evidence on the effectiveness and safety of interventions in chronic dialysis patients has been a subject of continuing criticism. Newtechnologies are often introduced into themarketwithout having specifically studied or even included patients with advanced kidney disease. Therefore, the need to generate valid effectiveness and safety data in this vulnerable subpopulation is of utmost importance. The US Food and Drug Administration has recently placed an increased focus on safety surveillance, and sponsors must now meet this additional postmarketing commitment. In patients with ESRD, the unique data collection environment in the United States allows for creative and efficient study designs to meet the needs of patients, providers, and sponsors. The purpose of this manuscript is to review the methodological and practical aspects of the different options for postmarketing study design in this field, with critical appraisal of their advantages and disadvantages.