Evidence map›Paper›PMID 32190807›Full record

ArticleJCO precision oncology2019

Discussion of Trial Designs for Biomarker Identification and Validation Through the Use of Case Studies.

Fang-Shu Ou, Ming-Wen An, Amy S Ruppert, Sumithra J Mandrekar

Abstract read
In one paragraph

Article in JCO precision oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Biomarker Discovery and Validation: Statistical Considerations.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2021
    Article
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

4 authors.

Fang-Shu OuMayo Clinic, Rochester, MN.
Ming-Wen AnVassar College, Poughkeepsie, NY.
Amy S RuppertThe Ohio State University, Columbus, OH.
Sumithra J MandrekarMayo Clinic, Rochester, MN.

Funding

Methodology for development, validation, and use of novel endpoints in oncologyR01CA174779 · NCI · MAYO CLINIC ROCHESTER · PI MANDREKAR, SUMITHRA JAY · 2014 to 2017
$1.2M
NCI NIH HHS R01 CA174779
6 · The paper itself

Abstract

With the launch of the National Cancer Institute's Precision Medicine Initiative in 2015, there has been a shift to trial designs that tailor health care solutions to individual patients by using a screening platform and by moving away from the one-trial/one-biomarker-at-a-time approach. To make precision medicine a reality, it is critical to identify and validate potential biomarkers to help select patients who will truly benefit from a targeted therapy. In this article, we discuss five trial designs: enrichment, umbrella, basket, subgroup, and window of opportunity. For each trial design, we describe the design characteristics, use ongoing or completed trials as case studies, provide any recent advances to the trial design, and discuss advantages and disadvantages of each design.

Identifiers

PMID32190807
PMCPMC7079723

What OpenQuestion holds

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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.