FDA to modernize oversight of clinical trials

New York, June 26 - The Food and Drug Administration said it is planning a series of policy and regulatory moves to strengthen its oversight and protection of patients in clinical trials.

The effort is also intended to improve the integrity of data from studies.

Part of the FDA's previously announced Critical Path Initiative, the changes to trial supervision will be called the Human Subject Protection and Bioresearch Monitoring Initiative (HSP/BIMO).

"As clinical trials continue to evolve, in particular becoming increasingly large, decentralized and global, the FDA's approach to bioresearch monitoring and human subject protection must also evolve and modernize," said Janet Woodcock, FDA deputy commissioner for operations.

"BIMO will help FDA modernize biomedical research monitoring making the most efficient use of its resources to help ensure the safe conduct of clinical trials, including taking appropriate opportunities to leverage existing oversight done by private entities to accomplish the agency's risk minimization goals."

The FDA said it has been carrying out an inventory of its programs over the past 18 months and has identified issues to launch the new initiative.

Woodcock will chair the steering committee.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.