Cited by 2,062Statistical Methods in Clinical TrialsStatistical Methods in EpidemiologyHealth and Medical Research Impacts

What are biomarkers?

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Strimbu, Kyle, Tavel, Jorge A·2010·Current Opinion in HIV and AIDS

Abstract

PURPOSE OF REVIEW: This article provides working definitions and a conceptual framework to understand the roles of biomarkers in clinical research. RECENT FINDINGS: The definitions of the terms discussed in this article--medical signs, symptoms, biomarkers, surrogate endpoints, clinical endpoints, validation--are still under discussion, as are their relationships to each other, but broad consensus has developed in the past decade and a half about the necessity of distinguishing between, in particular, surrogate and clinical endpoints. SUMMARY: This article outlines the major definitions of the key terms in this field and considers select cases in which misunderstandings about the terms led to flawed research conclusions.

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  • In the case of Alzheimer's disease, a biomarker can be used to assess the overall health and diseased condition of aged patients.

    “In the case of AD, a biomarker can be used to assess the overall health and diseased condition of aged patients [39, 40].”
  • Colchicine and icosapent ethyl have both demonstrated efficacy in reduction of CVD in recent large-scale phase III trials, however the precise mechanisms by which these drugs act, i.e. the causal intermediaries, remains elusive.

    “colchicine 53 and icosapent ethyl 97 have both demonstrated efficacy in reduction of CVD in 494 recent large-scale phase III trials, however the precise mechanisms by which these drugs act, 495 i.e. the causal intermediaries, remains elusive.”

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Authors
Strimbu, K., & Tavel, J. A.
Affiliations
National Institutes of Health (US)
Corresponding author
Tavel, Jorge A
Venue
Current Opinion in HIV and AIDS
Published
2010-11
Volume
5
Issue
6
Pages
463-466
ISSN
1746-630X (ISSN-L)
OpenAlex
W1980541833
Cited by
2,062
References
9
Citations by year
2026: 101 · 2025: 193 · 2024: 198 · 2023: 187 · 2022: 222 · 2021: 240 · 2020: 199 · 2019: 178 · 2018: 161 · 2017: 127 · 2016: 123 · 2015: 83 · 2014: 31 · 2013: 10 · 2012: 3
FWCI
4.08
Type
journal article
Language
en
Open access
Locations
  • Current Opinion in HIV and AIDS (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Institutes of Health (Z99 AI999999)
Topics
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
Keywords
biomarkers, surrogate endpoints, clinical trial endpoints, biomarker validation, terminology definitions
MeSH terms
Diagnosis, Humans, Reproducibility of Results, Biomarkers, Biomedical Research

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