Global Drug Development in a Rapidly Changing World, with Examples from HCV/HIV Trials

• Activity Number: 117
• Type: Topic Contributed
• Date/Time: Monday, August 2, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Regis Vilchez* and Carmen Mak+
• Companies: Merck Research Laboratories and Merck Research Laboratories
• Keywords: Multiregional Clincal Trials ; Global drug development ; HIV ; HCV ; anti-viral drug development

Abstract

Rapid improvement in treatment options have altered the landscape of drug development and created clinical and statistical hurdles unseen before. The recent approval and the development of potent antiviral agents for HIV and HCV have the potential to reduce deaths/serious sequela and present health care professionals with a plethora of treatment options that were not available a few years ago. Clinical trials of new drugs/ARV must now take into account treatment options, and this is complicated by the difference in standard of/access to care in different geographical regions. This talk will review the design, implementation and analyses of muti-regional clinical trials with examples from recent HIV and HCV drug development programs. Recommendations for the design and analyses of clinical programs in a fast changing social /clinical/regulatory/global environment will be made.