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

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. Author, Article, and Disclosure InformationAffiliations: National Institutes of Health Bethesda, Maryland 20892 PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited ByLongitudinal Data AnalysisHigh serum Aspartate transaminase levels on day 3 postliver transplantation correlates with graft and patient survival and would be a valid surrogate for outcome in liver transplantation clinical trialsStatistical evaluation of surrogate endpoints with examples from cancer clinical trialsSurrogate MarkersSurrogate EndpointsSurrogate EndpointsNeurologic Outcomes in HIV Infection: Clinical Events and Surrogate MarkersThe Role and Potential of Surrogate Outcomes in Clinical Trials: Have We Made Any Progress in the Past Decade?Idiopathic Pulmonary FibrosisA Statistical Appraisal of Biomarker Selection Methods Applicable to HIV/AIDS ResearchAn information-theoretic approach to surrogate-marker evaluation with failure time endpointsA unified framework for the evaluation of surrogate endpoints in mental-health clinical trialsRandom Effects Models for Longitudinal DataStatistical Criteria for Surrogate Endpoint and Applications: A ReviewSurrogate EndpointsSurrogate end points: hopes and perilsRequirements of a Good Biomarker: Translation into the Clinical LaboratoryThe meta-analytic framework for the evaluation of surrogate endpoints in clinical trialsSurrogate EndpointsSurrogate EndpointsIs Suicide Ideation a Surrogate Endpoint for Geriatric Suicide?Prentice's Approach and the Meta-Analytic Paradigm: A Reflection on the Role of Statistics in the Evaluation of Surrogate EndpointsA perspective on surrogate endpoints in controlled clinical trialsValidation of Biomarkers as Surrogates for Clinical EndpointsA Measure of the Proportion of Treatment Effect Explained by a Surrogate MarkerHuman Immunodeficiency Virus Type 1 RNA Level and CD4 Count as Prognostic Markers and Surrogate End Points: A Meta-AnalysisCD4 cell count as a surrogate endpoint in HIV clinical trialsTransforming Laboratory Test Results to Improve Clinical Outcome Predictions in HIV PatientsLymphocyte Phenotyping in Infants: Maturation of Lymphocyte Subpopulations and the Effects of HIV InfectionMarkers, Cofactors and Staging Systems in the Study of HIV Disease Progression: A ReviewSelecting and Validating Biologic Markers for Drug DevelopmentOral lesions as markers of severe immunosuppression in HIV-infected homosexual men and injection drug usersOn the use of auxiliary data to estimate the survival function and its variance: An application to acquired immunodeficiency syndromeComparison of the quality of life between HIV-positive haemophilia patients and HIV-negative haemophilia patientsSurrogate Biochemical Markers: Precise Measurement for Strategic Drug and Biologics DevelopmentIssues in the design and analysis of AIDS clinical trialsShort-term effects of lipid-based parenteral nutrition in patients with acquired immunodeficiency syndrome and Pneumocystis carinii pneumoniaStatistical issues in designing clinical trials of aids treatments and vaccinesSurrogate markers in aids and cancer trialsA Method for Evaluating Surrogate Markers When Measured with Error Using the Cox ModelThe CD4 + Lymphocyte and the Evaluation of Antiviral Drug Therapy in HIV InfectionOral manifestations associated with HIV-related disease as markers for immune suppression and AIDSThe utility of large, simple trials in the evaluation of AIDS treatment strategiesPeripheral blood mononuclear cell human immunodeficiency virus type 1 proviral DNA quantification by polymerase chain reaction: relationship to immunodeficiency and drug effectPresent Status and Future Prospects for HIV TherapiesSurrogate Markers in AIDSKofi Nuako, MD 1 April 1992Volume 116, Issue 7Page: 599-601KeywordsAIDSBiomarkersClinical trialsDrugsFood and Drug AdministrationHIVPrevention, policy, and public health Issue Published: 1 April 1992 PDF DownloadLoading ...