Monday, October 19, 2020 9:28:28 PM
•But, despite the challenge, the need to conduct clinical research internationally is stronger than ever
•The increasing shift from expert opinion towards evidence-based medicine enhances the importance of MRCTs
•In addition, the demand of Health Authorities (HAs) for high quality data is also increasing,
https://www.dellmed.com/
• From October 2007 to Sept 2008, clinical trials for medical products were conducted at nearly 6,500 foreign sites
– Western Europe accounted for 60% of total non-US sites
– The other 40% was nearly evenly divided: • Eastern Europe: 11%
• Asia/Pacific: 10%
• Non-U.S. North America: 8% • Central/South America: 8%
U.S. Department of Health and Human Services. 2010. Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials. Retrieved June 16, 2011, from http://oig.hhs
https://www.fda.gov/media/87406/download
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