The Food and Drug Administration's Oversight of Clinical Trials
The Food and Drug Administration's Oversight of Clinical Trials
WASHINGTON, DC, September 28, 2007-The Office of Inspector General (OIG) received a congressional request to review FDA oversight of clinical trials after a series of news articles highlighted vulnerabilities. The OIG aimed to determine the extent to which the Food and Drug Administration (FDA) conducted inspections of clinical trials from fiscal year (FY) 2000 to FY 2005, and to assess FDA’s processes for inspecting clinical trials. They found that data limitations and other factors inhibit FDA’s ability to effectively manage the bioresearch monitoring (BiMo program), and that the FDA inspected approximately 1 % of clinical trial sites during the fiscal year 2000–2005 period.
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Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
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