Study design issues in evaluating immune biomarkers

Ronald J. Bosch; Xinyan Zhang; Netanya G. Sandler

doi:10.1097/COH.0b013e32835d3259

Study design issues in evaluating immune biomarkers

Ronald J. Bosch, Xinyan Zhang, Netanya G. Sandler

Research output: Contribution to journal › Review article › peer-review

6 Scopus citations

Abstract

Purpose of review: 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. RECENT FINDINGS: 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. SUMMARY: Appropriate study design is essential in biomarker research.

Original language	English (US)
Pages (from-to)	147-154
Number of pages	8
Journal	Current Opinion in HIV and AIDS
Volume	8
Issue number	2
DOIs	https://doi.org/10.1097/COH.0b013e32835d3259
State	Published - Mar 2013
Externally published	Yes

Keywords

biomarker
clinical trials
measurement error
observational research
surrogate marker

ASJC Scopus subject areas

Immunology
Hematology
Oncology
Oncology(nursing)
Infectious Diseases
Virology

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10.1097/COH.0b013e32835d3259

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title = "Study design issues in evaluating immune biomarkers",

abstract = "Purpose of review: 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. RECENT FINDINGS: 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. SUMMARY: Appropriate study design is essential in biomarker research.",

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AU - Zhang, Xinyan

AU - Sandler, Netanya G.

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AB - Purpose of review: 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. RECENT FINDINGS: 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. SUMMARY: Appropriate study design is essential in biomarker research.

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Study design issues in evaluating immune biomarkers

Abstract

Keywords

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