New rules for US clinical trials and bioresearch

The US Food and Drug Administration has announced a series of new policy and regulatory developments to strenghten the agency's oversight and protection of patients in clinical trials, as well as to ensure the integrity of resulting data. The moves are part of the FDA's efforts to modernize bioresearch monitoring under the Critical Path Initiative. The new Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) initiative would encompass medical devices, food, human drugs, biological drug products and veterinary medicine.

The FDA's action is part of a Department of Health and Human Services-wide program to take advantage of "recent advances in basic science, including genomics and molecular analysis, in order to bring about more effective development and review of therapies and to enable increasingly targeted and individualized care management for patients," the agency said in a statement.

Janet Woodcock, the FDA's Deputy Commissioner for Operations, speaking at the Drug Information Association's annual general meeting, told her audience that, "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 evolve and modernize." Dr Woodcock added: "BIMO will help [the] 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."