FDA Aims to Modernize Clinical Trial Regulation

FDA's program will help ensure that clinical trials are conducted safely, says Janet Woodcock.

FDA in June unveiled a plan to transform oversight and protection of patients in clinical trials and change the agency's approach to bioresearch monitoring. The program, called the Human Subject Protection and Bioresearch Monitoring Initiative, applies to devices as well as other regulated industries.

FDA's bioresearch monitoring program includes inspections of investigators, sponsors, contract research organizations, institutional review boards (IRBs), and bioequivalence facilities. The task has grown more complex in recent years with the advent of electronic recordkeeping, the increase in the sheer numbers of trials, and a rise in the study of particularly vulnerable patients. The initiative will attempt to update FDA's practices to keep up with those trends.

The effort is part of the Critical Path Initiative to use recent advances in science and technology to bring about more-effective review and development of therapies.

“As clinical trials continue to evolve—in particular becoming increasingly large, decentralized, and global—FDA's approach to bioresearch monitoring and human subject protection must also evolve and modernize,” said Janet Woodcock. The FDA deputy commissioner for operations spoke during a presentation to the Drug Information Association in June. The program “will help FDA [make] 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.”

Projects to be part of the program include an effort to modernize adverse-event reporting to IRBs, making a rule on registration requirements for IRBs, and finalizing a rule on foreign clinical studies not conducted under an Investigational New Device exemption.