Bass, Berry & Sims attorney Clint Hermes examined some of the legal considerations for conducting clinical trials outside of the United States as part of the Practical Guidance Video series on Lexis+. In the video, Clint outlined some of the benefits and reasons why U.S. companies and institutions conduct clinical trials overseas, such as the ability to study diseases that cannot practically be studied in the U.S., potentially less burdensome regulatory requirements, and lower operational costs.
As Clint points out, there are also regulatory requirements companies must consider when conducting clinical trials outside of the United States. In addition to FDA regulations, Clint discussed the following U.S. laws a sponsor must also consider:
- Common Rule Agencies
- HIPAA
- Foreign Corrupt Practices Act
- Export Control Law
- Compliance with Local Laws
The video, “Geographical Considerations in International Clinical Trials,” is available on the Lexis+ website or on the Lexis Practical Guidance site (login required to access either Lexis platform). Clint provided additional guidance about various considerations when conducting international clinical trials in articles for LexisNexis and Law360.