A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing

被引:0
作者
Wang, Jixian [1 ]
Zhang, Hongtao [2 ]
Tiwari, Ram [3 ]
机构
[1] Bristol Myers Squibb, Boudry, Switzerland
[2] Merck & Co Inc, Biostat & Res Decis Sci, North Wales, PA USA
[3] Bristol Myers Squibb, Berkeley Hts, NJ USA
来源
STATISTICS IN BIOPHARMACEUTICAL RESEARCH | 2024年 / 16卷 / 02期
关键词
Bayesian bootstrap; Dynamic borrowing; Empirical Bayes; Power prior; Propensity score; INFERENCE;
D O I
10.1080/19466315.2023.2223533
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Use of historical control data to augment a small internal control arm in a randomized control trial (RCT) can lead to significant improvement of the efficiency of the trial. It introduces the risk of potential bias, since the historical control population is often rather different from the RCT. Power prior approaches have been introduced to discount the historical data to mitigate the impact of the population difference. However, even with a Bayesian dynamic borrowing which can discount the historical data based on the outcome similarity of the two populations, a considerable population difference may still lead to a moderate bias. Hence, a robust adjustment for the population difference using approaches such as the inverse probability weighting or matching, can make the borrowing more efficient and robust. In this article, we propose a novel approach integrating the propensity score for the covariate adjustment and Bayesian dynamic borrowing using power prior. The proposed approach uses Bayesian bootstrap in combination with the empirical Bayes (EB) method using quasi-likelihood for determining the power prior. The performance of our approach is examined by a simulation study. We apply the approach to two Acute Myeloid Leukemia (AML) studies for illustration.
引用
收藏
页码:182 / 191
页数:10
相关论文
共 31 条
  • [1] Bayesian estimation of the average treatment effect on the treated using inverse weighting
    Capistrano, Estelina S. M.
    Moodie, Erica E. M.
    Schmidt, Alexandra M.
    [J]. STATISTICS IN MEDICINE, 2019, 38 (13) : 2447 - 2466
  • [2] Bayesian Design of Noninferiority Trials for Medical Devices Using Historical Data
    Chen, Ming-Hui
    Ibrahim, Joseph G.
    Lam, Peter
    Yu, Alan
    Zhang, Yuanye
    [J]. BIOMETRICS, 2011, 67 (03) : 1163 - 1170
  • [3] AAML03P1, a pilot study of the safety of gemtuzumab ozogamicin in combination with chemotherapy for newly diagnosed childhood acute myeloid leukemia
    Cooper, Todd M.
    Franklin, Janet
    Gerbing, Robert B.
    Alonzo, Todd A.
    Hurwitz, Craig
    Raimondi, Susana C.
    Hirsch, Betsy
    Smith, Franklin O.
    Mathew, Prasad
    Arceci, Robert J.
    Feusner, James
    Iannone, Robert
    Lavey, Robert S.
    Meshinchi, Soheil
    Gamis, Alan
    [J]. CANCER, 2012, 118 (03) : 761 - 769
  • [4] de Finetti B., 1974, Theory of Probability
  • [5] European Medicines Agency, 2020, GUID REG BAS STUD
  • [6] Food and Drug Administration, 2018, US REAL WORLD EV SUP
  • [7] Gemtuzumab Ozogamicin in Children and Adolescents With De Novo Acute Myeloid Leukemia Improves Event-Free Survival by Reducing Relapse Risk: Results From the Randomized Phase III Children's Oncology Group Trial AAML0531
    Gamis, Alan S.
    Alonzo, Todd A.
    Meshinchi, Soheil
    Sung, Lillian
    Gerbing, Robert B.
    Raimondi, Susana C.
    Hirsch, Betsy A.
    Kahwash, Samir B.
    Heerema-McKenney, Amy
    Winter, Laura
    Glick, Kathleen
    Davies, Stella M.
    Byron, Patti
    Smith, Franklin O.
    Aplenc, Richard
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2014, 32 (27) : 3021 - +
  • [8] Approximate Bayesian Inference for Doubly Robust Estimation
    Graham, Daniel J.
    McCoy, Emma J.
    Stephens, David A.
    [J]. BAYESIAN ANALYSIS, 2016, 11 (01): : 47 - 69
  • [9] Power priors based on multiple historical studies for binary outcomes
    Gravestock, Isaac
    Held, Leonhard
    [J]. BIOMETRICAL JOURNAL, 2019, 61 (05) : 1201 - 1218
  • [10] Adaptive power priors with empirical Bayes for clinical trials
    Gravestock, Isaac
    Held, Leonhard
    [J]. PHARMACEUTICAL STATISTICS, 2017, 16 (05) : 349 - 360