US to modernise clinical trials and bioresearch monitoring rules

The US Food and Drug Administration (FDA) is introducing a series of new policy and regulatory developments to strengthen both the protection of clinical trial patients and the integrity of resulting data.

The move aims to modernise the FDA's approach to bioresearch monitoring as part of the Critical Path Initiative. The FDA said the Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) Initiative will employ recent advances in basic science, including genomics and molecular analysis, to bring about more effective development and review of therapies, and to enable increasingly targeted and individualised care management for patients.

"As clinical trials continue to evolve, in particular becoming increasingly large, decentralised and global, the FDA's approach to bioresearch monitoring and human subject protection must also evolve and modernise," said Janet Woodcock, FDA deputy commissioner for operations, at this year's Drug Information Association annual meeting.

"BIMO will help FDA modernise 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 minimisation goals."

Janet Woodcoc will chair the HSP/BIMO steering committee which is comprised of representatives from the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Food, Safety, and Nutrition (CFSAN), Center for Veterinary Medicine ( CVM ), Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC).