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Statistics in Biopharmaceutical Research Volume 15, 2023 - Issue 2
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Special Section: Estimands, Design and Analysis of Clinical Trials with Time-to-Event Outcomes

Nonproportional Hazards—An Evaluation of the MaxCombo Test in Cancer Clinical Trials

Yuan-Li Shena Office of Biostatistics, Office of Translational Science, FDA, Silver Spring, MDCorrespondence[email protected]
,
Xin Wanga Office of Biostatistics, Office of Translational Science, FDA, Silver Spring, MD
,
Mushti Sirishaa Office of Biostatistics, Office of Translational Science, FDA, Silver Spring, MD
,
Flora Mulkeya Office of Biostatistics, Office of Translational Science, FDA, Silver Spring, MD
,
Jiaxi Zhoua Office of Biostatistics, Office of Translational Science, FDA, Silver Spring, MD
,
Xin Gaoa Office of Biostatistics, Office of Translational Science, FDA, Silver Spring, MD
,
Lijun Zhanga Office of Biostatistics, Office of Translational Science, FDA, Silver Spring, MD
,
Thomas Gwisea Office of Biostatistics, Office of Translational Science, FDA, Silver Spring, MD
,
Shenghui Tanga Office of Biostatistics, Office of Translational Science, FDA, Silver Spring, MD
,
Marc Theoretb Oncology Center for Excellence (OCE), FDA, Silver Spring, MD
,
Richard Pazdurb Oncology Center for Excellence (OCE), FDA, Silver Spring, MD
&
Rajeshwari Sridharab Oncology Center for Excellence (OCE), FDA, Silver Spring, MD
 show all
Pages 300-309 | Received 02 Jul 2021, Accepted 22 Oct 2021, Published online: 04 Jan 2022

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Yuichiro Kaneko & Satoshi Morita. (2023) Determining the late effect parameter in the Fleming-Harrington test using asymptotic relative efficiency in cancer immunotherapy clinical trials. Journal of Biopharmaceutical Statistics 0:0, pages 1-20.
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Yuan-Li Shen, Sirisha Mushti, Flora Mulkey, Thomas Gwise, Xin Wang, Jiaxi Zhou, Xin Gao, Shenghui Tang, Marc R. Theoret, Richard Pazdur & Rajeshwari Sridhara. (2023) Rejoinder to Comments on “Non-Proportional Hazards – An Evaluation of the MaxCombo Test in Cancer Clinical Trials”. Statistics in Biopharmaceutical Research 15:2, pages 315-317.
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Ray S. Lin, Pralay Mukhopadhyay, Satrajit Roychoudhury, Keaven M. Anderson, Tianle Hu, Bo Huang, Larry F. Leon, Jason J. Z. Liao, Ji Lin, Rong Liu, Xiaodong Luo, Yabing Mai, Rui Qin, Kay Tatsuoka, Yang Wang, Jiabu Ye, Jian Zhu, Tai-Tsang Chen & Renee Iacona. (2023) Comment on “Non-Proportional Hazards – an Evaluation of the MaxCombo Test in Cancer Clinical Trials” by the Cross-Pharma Non-Proportional Hazards Working Group. Statistics in Biopharmaceutical Research 15:2, pages 312-314.
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Martin Posch, Robin Ristl & Franz König. (2023) Testing and Interpreting the “Right” Hypothesis—Comment on “Non-proportional Hazards — An Evaluation of the MaxCombo Test in Cancer Clinical Trials”. Statistics in Biopharmaceutical Research 15:2, pages 310-311.
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Articles from other publishers (1)

Pralay Mukhopadhyay, Jiabu Ye, Keaven M. Anderson, Satrajit Roychoudhury, Eric H. Rubin, Susan Halabi & Richard J. Chappell. (2022) Log-Rank Test vs MaxCombo and Difference in Restricted Mean Survival Time Tests for Comparing Survival Under Nonproportional Hazards in Immuno-oncology Trials. JAMA Oncology 8:9, pages 1294.
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