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Clinical Trial Designs for Evaluating the Medical Utility of Prognostic and Predictive Biomarkers in Oncology

Simon, Richard·2010·Personalized Medicine
DOI 10.2217/pme.09.49
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  • Many earlier molecular assays failed to achieve widespread adoption due to limited reproducibility, lack of external validation, and unclear incremental value beyond standard clinicopathologic variables.

    “Although some demonstrated initial associations with clinical outcomes, many failed to achieve widespread adoption due to limited reproducibility, lack of external validation, and unclear incremental value beyond standard clinicopathologic variables [15, 16].”

    From A decision-oriented framework for genomic testing across the prostate cancer continuum (2026) · cites this paper as [16]

    The Prognostic biomarkers passage (labelled Abstract; page unavailable) says that very few published prognostic factors are used in clinical practice. Another Abstract passage says retrospective studies often fail to show predictive value beyond standard prognostic factors. The paper emphasizes reproducibility and rigorous validation, but it does not establish that limited reproducibility and lack of external validation caused earlier molecular assays to go unused. (LLM, conf=0.85)

    Experimental — accuracy not yet measured

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Cited by

Sorted by citations

Authors
Simon, R.
Affiliations
National Cancer Institute, 9000 Rockville Pike, Bethesda, MD20892-7434, USA. Tel.: Fax:
Venue
Personalized Medicine
Publisher
Informa UK Limited
Published
2009-12-21
Volume
7
Issue
1
Pages
33-47
ISSN
  • 1741-0541
  • 1744-828X
DOI
10.2217/pme.09.49
Cited by
177
References
1
Language
en

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