4.6

CiteScore

2.2

Impact Factor
  • ISSN 1674-8301
  • CN 32-1810/R
Lihong Huang, Jianling Bai, Hao Yu, Feng Chen. Sample size re-estimation without un-blinding for time-to-event outcomes in oncology clinical trials[J]. The Journal of Biomedical Research, 2018, 32(1): 23-29. DOI: 10.7555/JBR.31.20160111
Citation: Lihong Huang, Jianling Bai, Hao Yu, Feng Chen. Sample size re-estimation without un-blinding for time-to-event outcomes in oncology clinical trials[J]. The Journal of Biomedical Research, 2018, 32(1): 23-29. DOI: 10.7555/JBR.31.20160111

Sample size re-estimation without un-blinding for time-to-event outcomes in oncology clinical trials

Funds: 

This research was supported by the National Natural Science Foundation of China (81273184), and the National Natural Science Foundation of China Grant for Young Scientists (81302512). We would like to thank the referees for their comments that greatly helped us improve the manuscript

More Information
  • Received Date: September 05, 2016
  • Revised Date: November 07, 2016
  • Sample size re-estimation is essential in oncology studies. However, the use of blinded sample size reassessment for survival data has been rarely reported. Based on the density function of the exponential distribution, an expectation-maximization (EM) algorithm of the hazard ratio was derived, and several simulation studies were used to verify its applications. The method had obvious variation in the hazard ratio estimates and overestimation for the relatively small hazard ratios. Our studies showed that the stability of the EM estimation results directly correlated with the sample size, the convergence of the EM algorithm was impacted by the initial values, and a balanced design produced the best estimates. No reliable blinded sample size re-estimation inference can be made in our studies, but the results provide useful information to steer the practitioners in this field from repeating the same endeavor.
  • Related Articles

    [1]Jubiao Zhang, Yang Chen, Lihong Yan, Xin Zhang, Xiaoyan Zheng, Junxia Qi, Fen Yang, Juxue Li. EphA3 deficiency in the hypothalamus promotes high-fat diet-induced obesity in mice[J]. The Journal of Biomedical Research, 2023, 37(3): 179-193. DOI: 10.7555/JBR.36.20220168
    [2]Solomon E. Owumi, Uche O. Arunsi, Moses T. Otunla, Imisioluwa O. Oluwasuji. Exposure to lead and dietary furan intake aggravates hypothalamus-pituitary-testicular axis toxicity in chronic experimental rats[J]. The Journal of Biomedical Research, 2023, 37(2): 100-114. DOI: 10.7555/JBR.36.20220108
    [3]Tiwari-Heckler Shilpa, Jiang Z. Gordon, Popov Yury, J. Mukamal Kenneth. Daily high-dose aspirin does not lower APRI in the Aspirin-Myocardial Infarction Study[J]. The Journal of Biomedical Research, 2020, 34(2): 139-142. DOI: 10.7555/JBR.33.20190041
    [4]Tao Chun'ai, Gan Yongxin, Su Weidong, Li Zhutian, Tang Xiaolan. Effectiveness of hospital disinfection and experience learnt from 11 years of surveillance[J]. The Journal of Biomedical Research, 2019, 33(6): 408-413. DOI: 10.7555/JBR.33.20180118
    [5]Huan Liu, Shijiang Zhang, Yongfeng Shao, Xiaohu Lu, Weidong Gu, Buqing Ni, Qun Gu, Junjie Du. Biomechanical characterization of a novel ring connector for sutureless aortic anastomosis[J]. The Journal of Biomedical Research, 2018, 32(6): 454-460. DOI: 10.7555/JBR.31.20170011
    [6]Minbo Zang, Qiao Zhou, Yunfei Zhu, Mingxi Liu, Zuomin Zhou. Effects of chemotherapeutic agent bendamustine for nonhodgkin lymphoma on spermatogenesis in mice[J]. The Journal of Biomedical Research, 2018, 32(6): 442-453. DOI: 10.7555/JBR.31.20170023
    [7]Huanqiang Wang, Congying Yang, Siyuan Wang, Tian Wang, Jingling Han, Kai Wei, Fucun Liu, Jida Xu, Xianzhen Peng, Jianming Wang. Cell-free plasma hypermethylated CASZ1, CDH13 and ING2 are promising biomarkers of esophageal cancer[J]. The Journal of Biomedical Research, 2018, 32(6): 424-433. DOI: 10.7555/JBR.32.20170065
    [8]Fengzhen Wang, Mingwan Zhang, Dongsheng Zhang, Yuan Huang, Li Chen, Sunmin Jiang, Kun Shi, Rui Li. Preparation, optimization, and characterization of chitosancoated solid lipid nanoparticles for ocular drug delivery[J]. The Journal of Biomedical Research, 2018, 32(6): 411-423. DOI: 10.7555/JBR.32.20160170
    [9]Christopher J. Danford, Zemin Yao, Z. Gordon Jiang. Non-alcoholic fatty liver disease: a narrative review of genetics[J]. The Journal of Biomedical Research, 2018, 32(6): 389-400. DOI: 10.7555/JBR.32.20180045
    [10]Sang R. Lee, Seung-yeon Lee, Sang-yun Kim, Si-yun Ryu, Bae-kuen Park, Eui-Ju Hong. Hydroxylation and sulfation of sex steroid hormones in inflammatory liver[J]. The Journal of Biomedical Research, 2017, 31(5): 437-444. DOI: 10.7555/JBR.31.20170031

Catalog

    Article Metrics

    Article views (3392) PDF downloads (290) Cited by()
    Related

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return