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
You may also be interested in...
IRB Reform Is Low-Hanging Fruit For FDA-Duke Clinical Trial Initiative
One of the first jobs for a new FDA/Duke University partnership aimed at modernizing clinical trials will be reforming policies for institutional review boards so studies can get off the ground more quickly, participants say
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.