Good Clinical Practice: Are Any Changes Expected in the United States?

Abstract

Over the last decades, there have been many important advancements in the approaches used for quality assurance and other aspects of good clinical practice (GCP). From a Food and Drug Administration (FDA) perspective, these represent refinements in the tools, but not changes in the fundamentals of GCP. The FDA will continue to place emphasis on the inspection of original records and procedures at the site of clinical studies. The FDA has not specified what particular internal procedures or standards should be used by drug developers and does not anticipate doing so in the future. The concept of GCP has, in part, led to the conceptualizing of good review practice (GRP) at the FDA. Identification of universally acceptable core GRP principles could be an appropriate subject of future international discussions.