Surrogate Markers in AIDS: Where Are We? Where Are We Going?

Abstract

Editorials1 April 1992Surrogate Markers in AIDS: Where Are We? Where Are We Going?Stephen W. Lagakos, PhD, Daniel F. Hoth, MDStephen W. Lagakos, PhD, Daniel F. Hoth, MDAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-116-7-599 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptDuring 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...References1. . Surrogate endpoints in evaluating the effectiveness of drugs against HIV infection and AIDS: September 11-12, 1989 Conference Summary. Robin Weiss and Leah Mazade; eds. Washington, D.C.: National Academy Press; 1990. Google Scholar2. Prentice R. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med. 1989;8:431-40. CrossrefMedlineGoogle Scholar3. MachadoGailEllenberg SMS. On the use of laboratory markers in the evaluation of treatment for HIV infection. J Acquir Immune Defic Syndr. 1990;3:1065-73. MedlineGoogle Scholar4. OsmondShiboskiBacchettiEingerMoss DSPEA. Immune activation markers and AIDS prognosis. AIDS. 1991;5:505-11. CrossrefMedlineGoogle Scholar This content is PDF only. To continue reading please click on the PDF icon. 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Affiliated Institutions

• Harvard University US
• National Institutes of Health US

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