Evidence map›Paper›PMID 25190513›Full record

ArticleBiostatistics (Oxford, England)2015

A discrete-time survival model with random effects for designing and analyzing repeated low-dose challenge experiments.

Chaeryon Kang, Ying Huang, Christopher J Miller

Abstract read
In one paragraph

Article in Biostatistics (Oxford, England), 2015. 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. 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

3 authors.

Chaeryon KangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.
Ying HuangVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA yhuang@fhcrc.org.
Christopher J MillerCenter for Comparative Medicine and California National Primate Research Center, University of California, Davis, CA 95616, USA.

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Marian Esvelt · 1985 to 2026
$296.4M
National Institute on Aging (NIA) ColonyP51OD011107 · OD · UNIVERSITY OF CALIFORNIA AT DAVIS · PI Simon J. Atkinson · 2012 to 2026
$191.5M
Statistical Methods in HIV Vaccine Efficacy TrialsR37AI054165 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert · 2010 to 2026
$6.7M
Statistical Methods for Evaluating Markers for Treatment SelectionR01CA152089 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI JANES, HOLLY · 2010 to 2021
$3.8M
Statistical Methods for Selection and Evaluation of BiomarkersR01GM106177 · NIGMS · FRED HUTCHINSON CANCER RESEARCH CENTER · PI HUANG, YING · 2013 to 2018
$1.6M
NCI NIH HHS P30 CA015704NCI NIH HHS R01 CA152089NIAID NIH HHS R37 AI054165NIAID NIH HHS R37AI05465NIGMS NIH HHS R01 GM106177NIH HHS P51 OD011107
6 · The paper itself

Abstract

Repeated low-dose (RLD) challenge designs are important in HIV vaccine research. Current methods for RLD designs rely heavily on an assumption of homogeneous risk of infection among animals, which, upon violation, can lead to invalid inferences and underpowered study designs. We propose to fit a discrete-time survival model with random effects that allows for heterogeneity in the risk of infection among animals and allows for predetermined challenge dose changes over time. Based on this model, we derive likelihood ratio tests and estimators for vaccine efficacy. A two-stage approach is proposed for optimizing the RLD design under cost constraints. Simulation studies demonstrate good finite sample properties of the proposed method and its superior performance compared to existing methods. We illustrate the application of the heterogeneous infection risk model on data from a real simian immunodeficiency virus vaccine study using Rhesus Macaques. The results of our study provide useful guidance for future RLD experimental design.

Indexed as

Likelihood FunctionsModels, StatisticalSurvival AnalysisAnimalsHIV InfectionsMacaca mulattaDiscrete-time survival model with random effectsHeterogeneous infection riskHIV vaccine prevention researchRepeated low-dose challenge experimentSample size calculation

Identifiers

PMID25190513
PMCPMC4786638

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.