...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 the current clinical trial system to ensure that it functions in keeping with the scientific and technical knowledge at hand. It is also critical to ensure 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, FDA and Duke University joined together as founding partners of a think tank, the Clinical Trials Transformation Initiative (CTFI), the goal of which is to modernize the mechanics of clinical trials and to increase their efficiency and productivity. The CTFI will oversee specific projects to identify existing issues related to current practice, design models for improvement, and test...

NOTE: All illustrations and photos have been removed from this article.



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