Clinical Trial Safety Surveillance in the New Regulatory and Harmonization Environment: Lessons Learned from the “Fialuridine Crisis”

Abstract

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory adverse event reporting requirements. Although harmonization of worldwide regulatory adverse event reporting requirements is a monumental achievement, developing safety surveillance guidelines that facilitate identification of the true safety profile of investigational products should be the focus of future harmonization efforts. This paper discusses and provides viewpoints on the “Fialuridine Crisis,” the Food and Drug Administration (FDA's) proposals to modify clinical trial safety surveillance requirements in the United States in response to the “Fialuridine Crisis,” and lessons learned. Thoughts on how to improve safety surveillance during clinical trials are presented.