Globalization of Clinical Trials: The Development of Treatments and Preventative Products for Diseases, with a Focus on Vaccines

• Activity Number: 531
• Type: Roundtables
• Date/Time: Wednesday, August 3, 2011 : 12:30 PM to 1:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Tammy Massie*+
• Companies: U.S. Food and Drug Administration
• Keywords: Globalization ; Clinical Trials ; Vaccines

Abstract

Pharmaceutical development has become a truly global phenomenon as more clinical trials are run in multiple countries & regions. Many issues have emerged-including statistical, clinical, regulatory, logistical, and ethical-reflecting the complex and multi-faceted nature of the problem and the often competing goals and objectives. This session will discuss issues and challenges associated with global vaccine development, but will be applicable to other regulated products including biologics, drugs & medical devices.

Clinical studies may be utilized in investigating and examining preventive and prophylactic treatments for infectious diseases that occur globally, including examples from the current global health crisis of diseases such as malaria, e. coli (travelers diarrhea), H1N1, and many other diseases that affect U.S. and non-U.S. residents.

Issues that commonly occur in these diseases include differences in standards of care, differences in baseline health status of subject populations, and even ability to recruit and retain subjects. Ensuring these issues are minimized are critical to pre-clinical to clinical studies.