Commentary on “Surrogate Endpoints in AIDS Drug Development: Current Status,” by Christy Chuang-Stein and Ralph Demasi *

Abstract

This paper offers commentary on “Surrogate Endpoints in AIDS Drug Development: Current Status” by Cristy Chuang-Stein and Ralph DeMasi which appears in this issue of the Drug Information Journal. Chuang-Stein and DeMasi pose the question: “Are researchers likely to be misled?” by surrogate endpoints, but the critical question is “How likely are researchers to be misled?” This commentary provides a brief review of AIDS treatments and knowledge. A reasonable strategy for assessing new HIV therapies might be to couple studies in pre-AIDS patients using viral load endpoints with studies in more advanced patients that can evaluate effects on clinical progression and mortality in a timely way. Researchers cannot answer the question “how likely” until they have seen marker and clinical data for a wide variety of products.