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Group sequential testing for cluster randomized trials with time-to-event endpoint.

Publication ,  Journal Article
Li, J; Jung, S-H
Published in: Biometrics
December 2022

We propose group sequential methods for cluster randomized trials (CRTs) with time-to-event endpoint. The alpha spending function approach is used for sequential data monitoring. The key to this approach is determining the joint distribution of test statistics and the information fraction at the time of interim analysis. We prove that the sequentially computed log-rank statistics in CRTs do not have independent increment property. We also propose an information fraction for group sequential trials with clustered survival data and a corresponding sample size determination approach. Extensive simulation studies are conducted to evaluate the performance of our proposed testing procedure using some existing alpha spending functions in terms of expected sample size and maximal sample size. Real study examples are taken to demonstrate our method.

Duke Scholars

Published In

Biometrics

DOI

EISSN

1541-0420

Publication Date

December 2022

Volume

78

Issue

4

Start / End Page

1353 / 1364

Location

England

Related Subject Headings

  • Statistics & Probability
  • Sample Size
  • Research Design
  • Randomized Controlled Trials as Topic
  • Computer Simulation
  • Cluster Analysis
  • 4905 Statistics
  • 0199 Other Mathematical Sciences
  • 0104 Statistics
 

Citation

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ICMJE
MLA
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Li, J., & Jung, S.-H. (2022). Group sequential testing for cluster randomized trials with time-to-event endpoint. Biometrics, 78(4), 1353–1364. https://doi.org/10.1111/biom.13498
Li, Jianghao, and Sin-Ho Jung. “Group sequential testing for cluster randomized trials with time-to-event endpoint.Biometrics 78, no. 4 (December 2022): 1353–64. https://doi.org/10.1111/biom.13498.
Li, Jianghao, and Sin-Ho Jung. “Group sequential testing for cluster randomized trials with time-to-event endpoint.Biometrics, vol. 78, no. 4, Dec. 2022, pp. 1353–64. Pubmed, doi:10.1111/biom.13498.
Li J, Jung S-H. Group sequential testing for cluster randomized trials with time-to-event endpoint. Biometrics. 2022 Dec;78(4):1353–1364.
Journal cover image

Published In

Biometrics

DOI

EISSN

1541-0420

Publication Date

December 2022

Volume

78

Issue

4

Start / End Page

1353 / 1364

Location

England

Related Subject Headings

  • Statistics & Probability
  • Sample Size
  • Research Design
  • Randomized Controlled Trials as Topic
  • Computer Simulation
  • Cluster Analysis
  • 4905 Statistics
  • 0199 Other Mathematical Sciences
  • 0104 Statistics