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FDA and Duke Launch Public-Private Partnership to Modernize Clinical Trials

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The U.S. Food and Drug Administration and Duke University Medical Center have begun a collaboration aimed at modernizing the way clinical trials are conducted.

Under an agreement between the organizations, Duke will host a Public-Private Partnership that will include broad representation from government, industry, patient advocacy groups, professional societies, and academia. The participants will work together to develop new standards and identify new methods and technologies that 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 M.D., 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."

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