What are biomarkers?
Open accessAbstract
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].”
From Recent Advancements in Pathogenesis, Diagnostics and Treatment of Alzheimer’s Disease (2020) · cites this paper as [39]
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.”
From Integrating genomics with biomarkers and therapeutic targets to invigorate cardiovascular drug development (2021) · cites this paper as [53]
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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)
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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