June 01, 2008
FDA may modernize trial oversight
The FDA has a stale and outdated regulatory system for overseeing clinical trial compliance, but several initiatives are under way to modernize it, according to Division of Scientific Investigations director Leslie Ball. Speaking at the Food and Drug Law Institute's annual meeting, Ball said the agency has high hopes for updating its clinical trial regulatory scheme under a “transformation initiative” in partnership with Duke University Medical Center.
Under the agreement, Duke will host a public-private partnership with broad representation from government, industry, patient advocacy groups, professional societies, and academia to develop new standards and identify new methods and technologies that improve safety, increase the quality of information derived from clinical trials, and make the research process more efficient.
Among ideas to be explored are: establishing national standards for a wide range of research functions to streamline current approaches to starting and conducting clinical trials; exploring alternative models for institutional review boards to minimize duplication of effort in multi-site clinical trials and identifying strategies to enhance the process of obtaining informed consent from trial participants; establishing accreditation programs for both clinical investigators and research sites; and extending technology use to improve data management.