Evidence map›Paper›PMID 34890525›Full record

ArticleJournal of biopharmaceutical statistics2022

Randomized two-stage optimal design for interval-censored data.

Guogen Shan

Abstract read
In one paragraph

Article in Journal of biopharmaceutical statistics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
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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

1 author.

Guogen ShanDepartment of Biostatistics, University of Florida, Gainesville, USA.ORCID 0000-0001-8690-6599

Funding

Alzheimer's Disease: New Trial Designs for Emerging ChallengesR01AG070849 · NIA · UNIVERSITY OF NEVADA LAS VEGAS · PI SHAN, GUOGEN · 2021 to 2025
$1.5M
Adaptive randomized designs for cancer clinical trials by using integer algorithms and exact Monte Carlo methodsR03CA248006 · NCI · UNIVERSITY OF FLORIDA · PI SHAN, GUOGEN · 2021 to 2022
$153k
NCI NIH HHS R03 CA248006NIA NIH HHS R01 AG070849
6 · The paper itself

Abstract

Interval-censored data occur in a study where the exact event time of each participant is not observed but it is known to be within a certain time interval. Multiple tests were proposed for such data, including the logrank test by Sun, the proportional hazard test by Finkelstein, and the Wilcoxon-type test by Peto and Peto. We propose sample size calculations based on these tests for a parallel one-stage or two-stage design. When the proportional hazard assumption is met, the proportional hazard test and the logrank test need smaller sample sizes than the Wilcoxon-type test, and the sample size savings are substantial. But this trend is reversed when the proportional hazard assumption does not hold, and the sample size savings using the Wilcoxon-type test are sizable. An example from a lung cancer clinical trial is used to illustrate the application of the proposed sample size calculations.

Indexed as

Proportional Hazards ModelsComputer SimulationHumansSample SizeSurvival AnalysisTime FactorsInterval-censored datarepeated measuressample sizesurvival datatwo-stage designs

Identifiers

PMID34890525
PMCPMC9133004

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.