Globalization of Biostatistics: The Development Treatments and Preventative Products for Infectious Diseases Including Applications in H1N1, Travelers Diarrhea, and/or Malaria

• Activity Number: 117
• Type: Topic Contributed
• Date/Time: Monday, August 2, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Tammy Massie*+
• Companies: FDA/CBER
• Keywords: Globalization ; Pandemic ; Infectious Diseases ; Safety ; Efficacy

Abstract

This talk 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 including examples from the current global health crisis of diseases such as malaria, e. coli (travelers diarrhea), H1N1 and many other diseases 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.

Ongoing discussions and collaborations and case studies may be included.