FDA, Duke partner to revamp clinical trials

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The FDA and Duke University Medical Center in Durham, N.C., have begun a collaboration to modernize the way clinical trials are conducted.

Under the terms of the agreement, Duke will host a public-private partnership, including representation from government, industry, patient advocacy groups, professional societies and academia. The participants will work to develop new standards and identify new methods and technologies to improve safety, boost the quality of information derived from clinical trials and make the research process more efficient.

“To ensure the safety of clinical trial participants and to improve the health of the public, the clinical research enterprise needs to evolve,” said Janet Woodcock MD, FDA deputy commissioner and chief medical officer. “It needs to be much more streamlined and efficient, and at the same time it needs to be better equipped to answer the pressing questions that confront both patients and health care professionals. Through this collaboration between FDA and Duke, we are going to work with many stakeholders to lay the foundation for achieving these goals.”

Woodcock leads the FDA's Critical Path Initiative to facilitate a national effort to modernize the scientific process through which a potential human drug, biological product or medical device is transformed from a discovery into a medical product.