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Monday, 10/19/2020 9:28:28 PM

Monday, October 19, 2020 9:28:28 PM

Post# of 44690
•Multinational Randomized Clinical Trials (MRCTs) are challenging
•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