The U.S. Food and Drug Administration (FDA) 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, MD, the deputy commissioner and chief medical officer who leads FDA’s Critical Path Initiative. “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.”

The partnership will be chaired by Robert M. Califf, MD, 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, MD, 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 topics that the initiative will explore are national standards for a wide range of research functions to streamline the current approaches for initiating and conducting clinical trials; alternative models for institutional review boards to minimize duplication of effort in multisite clinical trials and identify

accreditation programs for both clinical investigators and research sites; and the use of technology to improve data management.
 
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.

Source: http://www.dukehealth.org/HealthLibrary/News/10183