title: Study design issues in evaluating immune biomarkers.
abstract: OBJECTIVE
  The dramatic increase in the number and type of immune biomarkers that can be measured, particularly those assessing immune activation, has led to numerous investigations in HIV-infected individuals to explore pathogenesis and to assess therapeutic interventions that aim to attenuate immune activation. An overview is provided on study designs and related statistical and operational issues relevant to these investigations.
  
  
  RESULTS
  Cohort studies and nested case-control studies within these cohorts have identified multiple biomarkers that are associated with an increased risk of disease. Early-stage clinical trials of therapies to address these risks in HIV-infected individuals with viral suppression on antiretroviral therapy are a substantial focus of current HIV research.
  
  
  CONCLUSIONS
  Appropriate study design is essential in biomarker research.
authors: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts 02115, USA. rbosch@hsph.harvard.edu
authors: Ronald J
authors: RJ
authors: Bosch
authors: Xinyan
authors: X
authors: Zhang
authors: Netanya G
authors: NG
authors: Sandler
mesh_terms: D015415:Biomarkers; D035843:Biomedical Research / Q000379:methods*; D006678:HIV / Q000276:immunology*; D015658:HIV Infections / Q000276:immunology*; D006801:Humans; D015166:Monitoring, Immunologic / Q000379:methods; D012107:Research Design
chemical_list: D015415:Biomarkers
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