The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership to identify practices that through broad adoption will increase the quality and efficiency of clinical trials. Announced at the end of 2007 and formally established in 2008 by the U.S. Food and Drug Administration (FDA) and Duke University, CTTI now comprises more than 60 organizations from across the clinical trial enterprise.  Members include representatives of government agencies (the FDA, Centers for Medicare and Medicaid Services, Office of Human Research Protections, National Institutes of Health, and other national and international governmental bodies), industry representatives (pharmaceutical, biotech, device, and clinical research organizations), patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.