Evidence map›Paper›PMID 38487948›Full record

ReviewBiomarkers in medicine2024

Potential biomarkers in breast cancer drug development: application of the biomarker qualification evidentiary framework.

Eric Wang, Mackenzie Henderson, Priyanka Yalamanchili, Jenilee Cueto, Zahidul Islam, Charles Dharmani, Maribel Salas

Abstract readReview
In one paragraph

Review in Biomarkers in medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. 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.

Eric WangDaiichi-Sankyo, Inc., Basking Ridge, NJ 07920, USA.ORCID 0000-0002-9937-9959
Mackenzie HendersonDaiichi-Sankyo, Inc., Basking Ridge, NJ 07920, USA.ORCID 0000-0002-4401-8259
Priyanka YalamanchiliDaiichi-Sankyo, Inc., Basking Ridge, NJ 07920, USA.ORCID 0000-0002-5290-8665
Jenilee CuetoDaiichi-Sankyo, Inc., Basking Ridge, NJ 07920, USA.ORCID 0000-0002-8557-2635
Zahidul IslamDaiichi-Sankyo, Inc., Basking Ridge, NJ 07920, USA.ORCID 0000-0001-5928-224X
Charles DharmaniDaiichi-Sankyo, Inc., Basking Ridge, NJ 07920, USA.ORCID 0000-0003-3641-9738
Maribel SalasDaiichi-Sankyo, Inc., Basking Ridge, NJ 07920, USA.ORCID 0000-0001-5634-1558

Funding

Daiichi Sankyo Company
6 · The paper itself

Abstract

Breast cancer treatments have evolved rapidly, and clinically meaningful biomarkers have been used to guide therapy. These biomarkers hold utility within the drug development process to increase the efficiency and effectiveness. To this purpose, the US FDA developed an evidentiary framework. Literature searches conducted of literature published between 2016 and 2022 identified biomarkers in breast cancer. These biomarkers were reviewed for drug development utility through the biomarker qualification evidentiary framework. In the breast cancer setting, several promising biomarkers (ctDNA, Ki-67 and PIK3CA) were identified. There is a need for increased transparency regarding the requirements for qualification of specific biomarkers and increased awareness of the processes involved in biomarker qualification.

Indexed as

Biomarkers, TumorBreast NeoplasmsDrug DevelopmentAntineoplastic AgentsFemaleHumansAntineoplastic AgentsBiomarkers, Tumorbiomarkersbreast cancerdiagnosticdrug developmentframeworkmonitoringpredictiveprognosticqualificationreview

Identifiers

PMID38487948
PMCPMC11216506

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.