Globalization of Clinical Trials: The Development of Treatments and Preventative Products for Diseases and Allergies

• Activity Number: 380
• Type: Roundtables
• Date/Time: Tuesday, August 6, 2013 : 12:30 PM to 1:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Tammy Massie*+
• Companies: US-FDA-CBER
• Keywords: Globalization ; Clinical Trials ; Subgroup Analysis ; Allergenics ; Infectious Diseases

Abstract

Pharmaceutical development has become a truly global phenomenon as more clinical trials are run in multiple countries and 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 several key issues and challenges associated with global pharmaceutical development applicable to regulated pharmaceutical products.

This roundtable discussion will focus on the issues and challenges of organizing and implementing global clinical studies. These studies may be used 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, asthma, allergies, and many other diseases that affect U.S. and non-U.S. residents.

Issues that may occur include differences in standards of care, differences in baseline health status of subject populations, in disease or allergen exposure, and even ability to recruit and retain subjects.