Designing Global Development Programs
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Drug Information Journal, Vol. 33. pp. 353-356, 1999
Printed in the USA. All righfs reserved.
DESIGNING GLOBAL DEVELOPMENT PROGRAMS JEFFREY CHODAKEWITZ, MD Executive Director of Clinical Research-Infectious Diseases, Merck Research Laboratories, West Point, Pennsylvania
The global development of an anti-HIV agent can maximize the information that is available on the clinical utility and safety of a compound by broadening and diversifying the subject population studied. There is a tendency for viral diversity between different geographical regions, and variation in the management of subjects with Hn! across different regions, The two indinavir clinical endpoint studies illustrate the feasibility of successfully conducting clinical trials with broad geographic diversity. As more new compounds are developed in the future, the complexities inherent in this process will drive the need for a global perspective on HIV drug development. Key Words: Antiretroviral agents; Global development; Clinical endpoint studies
INTRODUCTION THERE IS A CLEAR RATIONALE for the global development of an anti-HIV agent, using a single development program to support worldwide registration. Although HIV is perceived as a single pathogen and disease, there is a tendency for viral diversity among different geographic regions. Differences in viral clades may be quite subtle, but may have biological and clinical impact, such as variation in the efficiency of heterosexual transmission. Thus, broadening the geographical diversity of clinical trials may improve our understanding of the impact of this viral diversity on the effectiveness of a new drug.
Presented at the DIA 34th Annual Meeting ‘Thinking Globally: Product Development, Registration and Marketing in the New Millennium,” June 7-1 l , 1998, Boston, Massachusetts. Reprint address: Dr.Jeffrey Chodakewitz, Clinical Research Infectious Diseases, B L 3 4 Merck Research Laboratories, P.O. Box 4, West Point, PA 19486.
Another rationale for global development is the medical issues surrounding the assessment of agents in such a complex disease as HIV. There is tremendous variability in how patients with HIV are treated across different countries. For example, there are differences in terms of when and what therapy is initiated. This impacts on the prior antiretroviral therapy that has been administered to subjects. In some countries, many of the subjects may have received very complex prior antiretroviral therapy, whereas in other regions the majority may be treatment-ndive. There are also variations in disease stages across different geographic areas. More clinically relevant information regarding the utility of a compound can be generated by including these different p o p lations in clinical trials. Conducting trials in many countries broadens and diversifies the patient populations that can be studied, making it easier to conduct specific clinical trials based on treatment patterns in a particular area. The resulting clinical experience may
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