Globalization of Biostatistics: The Development Treatments and Preventative Products for Infectious Diseases

• Activity Number: 198
• Type: Roundtables
• Date/Time: Monday, August 2, 2010 : 12:30 PM to 1:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Tammy Massie*+
• Companies: FDA/CBER
• Keywords: Globalization ; Safety ; Efficacy ; Pandemic ; Multi-Center

Abstract

This roundtable discussion will focus on the issues and challenges of organizing and implementing global clinical studies. These studies may be utilized in investigating and examining preventive and prophylactic treatments for infectious diseases that occur globally that affect both 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 prior to study inception or are clearly prospectively addressed facilitate seamless transitions from pre-clinical to clinical studies.