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

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What are biomarkers?

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

DOI 10.1097/coh.0b013e32833ed177PMC PMC3078627

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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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Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
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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
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2010-11
Volume: 5
Issue: 6
Pages: 463-466
ISSN: 1746-630X (ISSN-L)
DOI: 10.1097/coh.0b013e32833ed177
PMC: PMC3078627
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: green
www.ncbi.nlm.nih.gov
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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