FDA to Modernize BIMO Activities

As the Food and Drug Administration celebrated its 100th birthday in June, it unveiled a major initiative for overhauling how it regulates clinical trials and protects participants in research studies. In outlining the plan for the Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) initiative at the annual meeting of the Drug Information Association (DIA), Deputy Commissioner for Operations Janet Woodcock noted that it reflects the emergence of an "increasingly large, decentralized, and global" research enterprise. She cited the need to respond to dramatic changes in the nature and conduct of clinical research characterized by:

a steady increase in the number of clinical trial studies and sites in the United States and abroad
larger trials involving many small, individual sites
proliferation of different electronic record-keeping methods and systems for data collection and processing

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