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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."
Woodcock leads FDA's Critical Path Initiative, aimed at facilitating a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or "proof of concept" into a medical product. The agency has entered into a number of partnerships to address key priority areas of the initiative. This partnership will be chaired by Robert M. Califf, M.D., vice chancellor for clinical research at Duke University and will provide a venue to convene working groups and a national panel of experts. Rachel Behrman, M.D., director of FDA's Office of Critical Path Programs, will co-chair the partnership.
"Society is appropriately demanding more evidence about medical practice," said Califf. "Indeed, there is concern that our research system is falling behind the needs of society to determine the balance of benefit and risk from drugs, devices and surgical procedures. Our system of clinical trials provides the evidence for what the FDA approves and which medical practices are adopted as professional standards. We aim to provide a forum in which the experts in the field can put forward ideas about how to improve the system and then we can do research to inform policy makers about whether suggested changes are likely to have beneficial effects."
Among the ideas that the initiative will explore:
The initiative will begin by identifying simple measures in areas where there is strong consensus across the clinical research community that better procedures can be established. The complete set of recommendations will take several years to develop.
"This effort is driven by the recognition that the science governing the development of effective drugs, devices, and procedures is advancing rapidly," said Woodcock. "The FDA is looking forward to working with Duke to convene the best talent we can find to inform us about what can be done to improve the clinical trials that form the basis for our regulation of drugs and devices."