Evidence map›Paper›PMID 42422045›Full record

ArticleStatistics in biopharmaceutical research2025

Group Sequential Design and Monitoring of Clustered Data in Randomized Eye Trials.

Guoqing Diao, Qiang Zhang, Toshimitsu Hamasaki, Scott Evans

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Statistics in biopharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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.

Guoqing DiaoDepartment of Biostatistics and Bioinformatics, The George Washington University, Washington, D.C.
Qiang ZhangVickie and Jack Farber Vision Research Center at Wills Eye Hospital, Philadelphia, P.A.
Toshimitsu HamasakiDepartment of Biostatistics and Bioinformatics, The George Washington University, Washington, D.C.
Scott EvansDepartment of Biostatistics and Bioinformatics, The George Washington University, Washington, D.C.

Funding

Unified group sequential designs for clustered data (eye level) in randomized eye trialsR21EY032951 · NEI · GEORGE WASHINGTON UNIVERSITY · PI DIAO, GUOQING, ZHANG, QIANG · 2022 to 2023
$462k
NEI NIH HHS R21 EY032951
6 · The paper itself

Abstract

Group sequential designs are the most commonly used methods for randomized clinical trials with interim monitoring plans, which control the type I error rate and protect statistical power. However, to the best of our knowledge, group sequential methods accounting for the inter-eye correlation under a unified design in randomized eye trials, do not exist in the literature. Failing to account for inter-eye correlations may lead to unnecessary study continuation or early stopping. We propose a unified group sequential design for vision research that accommodates all possible design options while accounting for inter-eye correlations when both eyes of a patient are included in the study for at least some patients. We derive closed-form formulae for the sample size/power calculations for fixed-sample designs and the information fractions during interim monitoring for group sequential designs while accounting for the inter-eye correlation for continuous endpoints. Simulation studies and an application to the Age-Related Eye Disease Study are provided. An R package

Indexed as

adaptive designalpha spendinginformation timeinterim analysislinear mixed modelsample size/power calculation

Identifiers

PMID42422045
PMCPMC13344445

What OpenQuestion holds

Textmetadata
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.