Stephen W. Lagakos, PhD; Daniel F. Hoth, MD
During the last several years, extensive research has been done on surrogate markers in patients with the acquired immunodeficiency syndrome (AIDS) (1). However, many questions remain about the use of these markers in the design and implementation of clinical trials for early approval of new drugs to combat the human immunodeficiency virus (HIV), and for patient management. For example, can short-term treatment effects on CD4 cell counts observed during comparative clinical trials of new drugs be reliably used to predict long-term clinical effects? Should the Food and Drug Administration (FDA) use laboratory markers as surrogates for clinical effect in the
Lagakos SW, Hoth DF. Surrogate Markers in AIDS: Where Are We? Where Are We Going?. Ann Intern Med. ;116:599–601. doi: 10.7326/0003-4819-116-7-599
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Published: Ann Intern Med. 1992;116(7):599-601.
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