The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.
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 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]
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“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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Citations
Cites
Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
Biomarkers Definitions Working Group (2001) · Clinical Pharmacology & Therapeutics · doi:10.1067/mcp.2001.113989 · Cited by 6,771
Surrogate End Points in Clinical Trials: Are We Being Misled?
Fleming, T. R., & DeMets, D. L. (1996) · Annals of Internal Medicine · doi:10.7326/0003-4819-125-7-199610010-00011 · Cited by 1,651
A Controlled Trial of Interferon Gamma to Prevent Infection in Chronic Granulomatous Disease
The International Chronic Granulomatous Disease Cooperative Study Group* (1991) · New England Journal of Medicine · doi:10.1056/nejm199102213240801 · Cited by 832
Surrogate endpoints in clinical trials: Cardiovascular diseases
Wittes, J. T., Lakatos, E., & Probstfield, J. L. (1989) · Statistics in Medicine · doi:10.1002/sim.4780080405 · Cited by 255
Surrogate endpoints in clinical trials: Cancer
Ellenberg, S. S., & Hamilton, J. M. (1989) · Statistics in Medicine · doi:10.1002/sim.4780080404 · Cited by 166
Perspective: Validating Surrogate Markers--Are We Being Naive?
Gruttola, V. D., Fleming, T. R., Lin, D. Y., & Coombs, R. W. (1997) · The Journal of Infectious Diseases · doi:10.1093/infdis/175.2.237 · Cited by 130
Zen‐Yōji, H., Clair, R. A. L., Ohta, K., & Montague, T. S. (1973) · The Journal of Infectious Diseases · doi:10.1093/infdis/127.3.237 · Cited by 48
Debate: The slippery slope of surrogate outcomes
D’Agostino, R. B. (2000) · Trials · doi:10.1186/cvm-1-2-076 · Cited by 46
Controversies Surround Heart Drug Study
Mitka, M. (2008) · JAMA · doi:10.1001/jama.299.8.885 · Cited by 25
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The epidemiology of global micronutrient deficiencies
Bailey, R. L., West Jr., K. P., & Black, R. E. (2015) · Annals of Nutrition and Metabolism · doi:10.1159/000371618 · Cited by 2,035
The COMET Handbook: version 1.0
Williamson, P. R., Altman, D. G., Bagley, H., Barnes, K. L., Blazeby, J. M., Brookes, S. T., Clarke, M., Gargon, E., Gorst, S., Harman, N., et al. (2017) · Trials · doi:10.1186/s13063-017-1978-4 · Cited by 2,011
The immune contexture and Immunoscore in cancer prognosis and therapeutic efficacy
Bruni, D., Angell, H. K., & Galon, J. (2020) · Nature reviews. Cancer · doi:10.1038/s41568-020-0285-7 · Cited by 1,586
Wearable and flexible electronics for continuous molecular monitoring
Yang, Y., & Gao, W. (2019) · Chemical Society Reviews · doi:10.1039/c7cs00730b · Cited by 1,315
Grip Strength: An Indispensable Biomarker For Older Adults
Bohannon, R. W. (2019) · Clinical Interventions in Aging · doi:10.2147/cia.s194543 · Cited by 994
Metadata
- 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
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