Strengthening the Regulation of Clinical Trials and Bioresearch Monitoring

The Food and Drug Administration has announced new policy and regulatory developments to strengthen the agency's oversight and protection of patients in clinical trials and the integrity of resulting data. The Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) initiative will help modernize the agency's approach to bioresearch monitoring of devices, foods, human drugs, biological drug products, and veterinary medicine.

The initiative is part of a larger effort of the U.S. Department of Health and Human Services to employ recent advances, including genomics and molecular analysis, to bring about more effective development and review of therapies.

"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 FDA Deputy Commissioner for Operations Janet Woodcock, M.D., at the annual meeting of the Drug Information Association in June 2006. "BIMO will help the FDA make the most efficient use of its resources to 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."

Clinical trials have evolved dramatically since the FDA first began inspecting them in 1977. Over time, the FDA has established a bioresearch monitoring program to protect the rights and welfare of human subjects and to verify the quality and integrity of data submitted for review. The program includes the development and implementation of compliance programs guiding inspections of investigators, sponsors, contract research organizations, institutional review boards (IRBs), and bioequivalence facilities.

With the expansion of clinical trial studies and sites, electronic record-keeping in the studies, and greater participation by vulnerable subjects in clinical trials, the role of the FDA's bioresearch monitoring compliance programs must expand as well. The HSP/BIMO initiative addresses this need.

Since 2004, the FDA has carefully inventoried its programs and identified issues to launch the HSP/BIMO initiative. As this initiative moves forward, the FDA will continue to gather additional issues and related information from internal and external stakeholders—industry, academic institutions, and government programs. The agency intends to conduct workshops and to create other opportunities for public input.

Woodcock will chair the HSP/BIMO steering committee, comprising representatives from the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the Office of Regulatory Affairs, and the Office of the Commissioner.

Here are some highlights of what has been completed:

Draft Guidance: Process for Handling Referrals to FDA Under 21 CFR 50.54; Additional Safeguards for Children in Clinical Investigations, published May 2006
Guidance for Industry: Using a Centralized IRB Process in Multicenter Clinical Trials, published in March 2006
Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, published in March 2006
Information Sheet Guidances for IRBs, Clinical Investigators, and Sponsors, five published in January 2006.

Projects in progress:

Modernizing adverse event reporting to IRBs to accommodate a major trend toward multicenter trials. In March 2005, the FDA held a hearing on adverse event reporting to IRBs, and is working on a draft guidance.
Published proposed rule: Institutional Review Board-Registration Requirements. The FDA is reviewing comments.
Finalizing rule: Foreign Clinical Studies not Conducted Under an IND (21 CFR 312.120).

For More Information

Good Clinical Practice in FDA-Regulated Clinical Trials

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