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Sample size calculation for clustered survival data under subunit randomization.

Publication ,  Journal Article
Li, J; Jung, S-H
Published in: Lifetime Data Anal
January 2022

Each cluster consists of multiple subunits from which outcome data are collected. In a subunit randomization trial, subunits are randomized into different intervention arms. Observations from subunits within each cluster tend to be positively correlated due to the shared common frailties, so that the outcome data from a subunit randomization trial have dependency between arms as well as within each arm. For subunit randomization trials with a survival endpoint, few methods have been proposed for sample size calculation showing the clear relationship between the joint survival distribution between subunits and the sample size, especially when the number of subunits from each cluster is variable. In this paper, we propose a closed form sample size formula for weighted rank test to compare the marginal survival distributions between intervention arms under subunit randomization, possibly with variable number of subunits among clusters. We conduct extensive simulations to evaluate the performance of our formula under various design settings, and demonstrate our sample size calculation method with some real clinical trials.

Duke Scholars

Published In

Lifetime Data Anal

DOI

EISSN

1572-9249

Publication Date

January 2022

Volume

28

Issue

1

Start / End Page

40 / 67

Location

United States

Related Subject Headings

  • Statistics & Probability
  • Sample Size
  • Research Design
  • Random Allocation
  • Humans
  • Cluster Analysis
  • 4905 Statistics
  • 0104 Statistics
 

Citation

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MLA
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Li, J., & Jung, S.-H. (2022). Sample size calculation for clustered survival data under subunit randomization. Lifetime Data Anal, 28(1), 40–67. https://doi.org/10.1007/s10985-021-09538-0
Li, Jianghao, and Sin-Ho Jung. “Sample size calculation for clustered survival data under subunit randomization.Lifetime Data Anal 28, no. 1 (January 2022): 40–67. https://doi.org/10.1007/s10985-021-09538-0.
Li J, Jung S-H. Sample size calculation for clustered survival data under subunit randomization. Lifetime Data Anal. 2022 Jan;28(1):40–67.
Li, Jianghao, and Sin-Ho Jung. “Sample size calculation for clustered survival data under subunit randomization.Lifetime Data Anal, vol. 28, no. 1, Jan. 2022, pp. 40–67. Pubmed, doi:10.1007/s10985-021-09538-0.
Li J, Jung S-H. Sample size calculation for clustered survival data under subunit randomization. Lifetime Data Anal. 2022 Jan;28(1):40–67.
Journal cover image

Published In

Lifetime Data Anal

DOI

EISSN

1572-9249

Publication Date

January 2022

Volume

28

Issue

1

Start / End Page

40 / 67

Location

United States

Related Subject Headings

  • Statistics & Probability
  • Sample Size
  • Research Design
  • Random Allocation
  • Humans
  • Cluster Analysis
  • 4905 Statistics
  • 0104 Statistics