Duke, FDA partner on clinical trial modernization
This article was originally published in The Gray Sheet
Executive Summary
FDA and Duke University Medical Center are teaming up to modernize the way clinical trials are conducted, spearheading a public-private partnership of government, industry, health care and academic stakeholders, the organizations say. An executive and steering committee will develop new standards and identify ways to improve safety, quality of information and the research process. Key initiatives include setting national standards for things like electronic data forms and contractual agreements to streamline a "too slow and unnecessarily complicated" process, and creating accreditation programs for clinical investigators and research sites. Duke's Robert M. Califf, MD, and FDA's Rachel Behrman, director of the agency's office of critical path programs, will co-chair the partnership
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