Evidence map›Paper›PMID 31598964›Full record

ArticleBiometrics2020

Designing precision medicine trials to yield a greater population impact.

Ying-Qi Zhao, Michael L LeBlanc

Abstract read
In one paragraph

Article in Biometrics, 2020. 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. Article
  2. A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design.Statistics in biopharmaceutical research · 2024
    Article
  3. 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

2 authors.

Ying-Qi ZhaoPublic Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.ORCID 0000-0002-2851-2257
Michael L LeBlancPublic Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Marian Esvelt · 1985 to 2026
$296.4M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MEGAN OTHUS · 2014 to 2026
$115.2M
Statistical methods for healthcare in complex patients with diabetesR01DK108073 · NIDDK · FRED HUTCHINSON CANCER RESEARCH CENTER · PI ZHAO, YINGQI · 2015 to 2019
$1.5M
NCI NIH HHS P30 CA015704NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180888NIDDK NIH HHS R01 DK108073
6 · The paper itself

Abstract

Traditionally, a clinical trial is conducted comparing treatment to standard care for all patients. However, it could be inefficient given patients' heterogeneous responses to treatments, and rapid advances in the molecular understanding of diseases have made biomarker-based clinical trials increasingly popular. We propose a new targeted clinical trial design, termed as Max-Impact design, which selects the appropriate subpopulation for a clinical trial and aims to optimize population impact once the trial is completed. The proposed design not only gains insights on the patients who would be included in the trial but also considers the benefit to the excluded patients. We develop novel algorithms to construct enrollment rules for optimizing population impact, which are fairly general and can be applied to various types of outcomes. Simulation studies and a data example from the SWOG Cancer Research Network demonstrate the competitive performance of our proposed method compared to traditional untargeted and targeted designs.

Indexed as

AlgorithmsBiomarkersBiomarkers, TumorBiometryClinical Trials as TopicClinical Trials, Phase III as TopicComputer SimulationHumansLinear ModelsMaleModels, StatisticalPrecision MedicineProportional Hazards ModelsProstatic Neoplasms, Castration-ResistantSample SizeTreatment OutcomeBiomarkersBiomarkers, Tumorbiomarkerspopulation impactprecision medicinetargeted clinical trial design

Identifiers

PMID31598964
PMCPMC7211185

What OpenQuestion holds

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LicenceTDM
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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.