Evidence map›Paper›PMID 37941446›Full record

ReviewJournal of the National Cancer Institute2024

Revisiting the standard blueprint for biomarker development to address emerging cancer early detection technologies.

Ruth Etzioni, Roman Gulati, Christos Patriotis, Carolyn Rutter, Yingye Zheng, Sudhir Srivastava, Ziding Feng

Open access · bronzeAbstract readReview
In one paragraph

Review in Journal of the National Cancer Institute, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Late-Stage Outcomes as Surrogates for Mortality in Cancer Screening Trials: A Systematic Review and Meta-analysis.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2025
    Pooled it
  2. Pooled it
  3. Review
  4. Urinary 27-nor-5β-cholestane-3α,7α,12α,24medRxiv : the preprint server for health sciences · 2026
    Article
  5. Review
  6. Article
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  9. Review
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  13. Early detection of pancreatic cancer: Study design and analytical considerations in biomarker discovery and early phase validation studies.Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] · 2024
    Review
  14. Review
  15. Designing Rigorous and Efficient Clinical Utility Studies for Early Detection Biomarkers.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2024
    Article
  16. Review
  17. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Ruth EtzioniDivision of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-9164-6370
Roman GulatiDivision of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-7592-6567
Christos PatriotisDivision of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.ORCID 0000-0001-6441-776X
Carolyn RutterDivision of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, WA, USA.
Yingye ZhengDivision of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0002-3078-4200
Sudhir SrivastavaDivision of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.ORCID 0000-0002-7798-9772
Ziding FengDivision of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, WA, USA.ORCID 0000-0003-3051-8882
Fred Hutch Cancer Center · USNational Cancer Institute · US

Funding

The Early Detection Research Network: Data Management and Coordinating CenterU24CA086368 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI RUTH D ETZIONI, Ziding Feng · 2010 to 2026
$75.7M
Modeling and analytics for cancer diagnostics: traversing the data-evidence divideR35CA274442 · NCI · FRED HUTCHINSON CANCER CENTER · PI RUTH D ETZIONI · 2022 to 2026
$4.9M
Statistical modeling to support population and translational cancer researchR50CA221836 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Roman Gulati · 2017 to 2026
$2.0M
Accelerating biomarker development through novel statistical methods for analyzing phase III/IV studiesR01CA277133 · NCI · FRED HUTCHINSON CANCER CENTER · PI Ying Huang · 2023 to 2026
$1.6M
NCI NIH HHS R01 CA277133NCI NIH HHS R35 CA274442NCI NIH HHS R35CA274442NCI NIH HHS R50 CA221836NCI NIH HHS U24 CA086368
6 · The paper itself

Abstract

Novel liquid biopsy technologies are creating a watershed moment in cancer early detection. Evidence supporting population screening is nascent, but a rush to market the new tests is prompting cancer early detection researchers to revisit the standard blueprint that the Early Detection Research Network established to evaluate novel screening biomarkers. In this commentary, we review the Early Detection Research Network's Phases of Biomarker Development (PBD) for rigorous evaluation of novel early detection biomarkers and discuss both hazards and opportunities involved in expedited evaluation. According to the PBD, for a biomarker-based test to be considered for population screening, 1) test sensitivity in a prospective screening setting must be adequate, 2) the shift to early curable stages must be meaningful, and 3) any stage shift must translate into clinically significant mortality benefit. In the past, determining mortality benefit has required lengthy randomized screening trials, but interest is growing in expedited trial designs with shorter-term endpoints. Whether and how best to use such endpoints in a manner that retains the rigor of the PBD remains to be determined. We discuss how computational disease modeling can be harnessed to learn about screening impact and meet the needs of the moment.

Indexed as

Early Detection of CancerNeoplasmsBiomarkersHumansProspective StudiesBiomarkers

Identifiers

PMID37941446
PMCPMC10852609
OpenAlexW4388515808

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.