Clinical Trials Transformation Initiative

 

 

As our understanding of disease pathophysiology and etiology deepens, particularly in the era of genomic medicine, the knowledge we gain must be applied to drug development, beginning in exploratory testing and continuing through clinical development, on into postmarket use.  One important goal is to increasingly personalize treatment—customize interventions to the people who are likely to benefit while avoiding people for whom the risks are likely to outweigh potential benefits. 

Clinical trials are a critical tool for determining which preventive, diagnostic, and/or therapeutic interventions have value and to compare alternative treatments. As the numbers and complexities of trials increase and as new technologies emerge and become more sophisticated, it is important to evaluate our current clinical trial system to ensure that it is functioning commensurate with the scientific and technical knowledge at hand.  It is also critical to make sure we are maximizing the safety and protection of trial participants.  The success of the clinical trial system will depend on continued public confidence in its safety, integrity, and transparency. 

In light of these issues, the Food and Drug Administration (FDA) and Duke University have joined together as founding partners of a thinktank, the Clinical Trials Transformation Initiative (CTTI), the goal of which is to modernize the clinical trial system.  The CTTI will oversee specific projects to identify existing issues related to current practice, design models for improvement, and test the new models and compare them to the existing system.

• Expert Meeting Presentations on Standardized Data Collection for Cardiovascular Trials, September 11, 2009
• Grant Opportunity - Clinical Trials Transformation Initiative (U19), June 19, 2009
  • Federal Register Notice
• Announcement of CTTI Executive Board Members, May 5, 2008  
• Announcement of Public Private Partnership to Modernize Clinical Trials, November 26, 2007
• Memorandum of Understanding for Public Private Partnership (Federal Register, November 23, 2007)

For additional details on this initiative, please see the CTTI Web site.

Contact:  Melissa Robb, Office of Critical Path Programs
301-796-5227
melissa.robb@fda.hhs.gov