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New FDA Regulations Boost Monitoring of Clinical Trials

Changes aimed at strengthening protection of patients and data integrity

WEDNESDAY, June 28 (HealthDay News) -- The U.S. Food and Drug Administration has announced a range of policy and regulatory developments aimed at strengthening the agency's protection of patients and the integrity of data from clinical trials.

The Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) Initiative covers human drugs, biological drug products, devices, foods and veterinary medicine, and is part of a broader process to make use of recent scientific advances, specifically in the areas of genomics and molecular analysis.

"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, in a statement.

The initiative addresses several recent changes in the conduct of clinical trials, such as electronic record-keeping in studies and greater participation in clinical trials by vulnerable subjects. Other issues for the initiative will be added as the project evolves, based on feedback from industry, academic and government stakeholders.

"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," said Woodcock.

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