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A Weighted Risk Set Estimator for Survival Distributions in Two-Stage Randomization Designs with Censored Survival Data

Author

Listed:
  • Guo Xiang

    (North Carolina State University)

  • Tsiatis Anastasios

    (North Carolina State University)

Abstract

In many clinical trials related to diseases such as cancers and HIV, patients are treated by different combinations of therapies. This leads to two-stage designs, where patients are initially randomized to a primary therapy and then depending on disease remission and patients' consent, a maintenance therapy will be randomly assigned. In such designs, the effects of different treatment policies, i.e., combinations of primary and maintenance therapy are of great interest. In this paper, we propose an estimator for the survival distribution for each treatment policy in such two-stage studies with right-censoring using the method of weighted estimation equations within risk sets. We also derive the large-sample properties. The method is demonstrated and compared with other estimators through simulations and applied to analyze a two-stage randomized study with leukemia patients.

Suggested Citation

  • Guo Xiang & Tsiatis Anastasios, 2005. "A Weighted Risk Set Estimator for Survival Distributions in Two-Stage Randomization Designs with Censored Survival Data," The International Journal of Biostatistics, De Gruyter, vol. 1(1), pages 1-17, May.
    • Handle: RePEc:bpj:ijbist:v:1:y:2005:i:1:n:1
    DOI: 10.2202/1557-4679.1000
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    Citations

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    Cited by:

    1. Tang, Xinyu & Melguizo, Maria, 2015. "DTR: An R Package for Estimation and Comparison of Survival Outcomes of Dynamic Treatment," Journal of Statistical Software, Foundation for Open Access Statistics, vol. 65(i07).
    2. Yasuhiro Hagiwara & Tomohiro Shinozaki & Hirofumi Mukai & Yutaka Matsuyama, 2021. "Sensitivity analysis for subsequent treatments in confirmatory oncology clinical trials: A two‐stage stochastic dynamic treatment regime approach," Biometrics, The International Biometric Society, vol. 77(2), pages 702-714, June.
    3. Chaffee Paul H. & van der Laan Mark J., 2012. "Targeted Maximum Likelihood Estimation for Dynamic Treatment Regimes in Sequentially Randomized Controlled Trials," The International Journal of Biostatistics, De Gruyter, vol. 8(1), pages 1-32, June.

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