The Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) initiative will facilitate the modernization of the regulation of clinical trials and bioresearch monitoring, specifically the protection of human subjects and the integrity of data in clinical trials, and encompasses devices, foods, human drugs, biological drug products and veterinary medicine.
The new effort is part of a US Department of Health and Human Services (HHS)-wide initiative to employ 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.
Among the many projects underway as part of the initiative is a scheme to modernize adverse event reporting to institutional review boards to accommodate a major trend toward multicenter trials.
“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, at this year's Drug Information Association annual meeting. “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.”