Advanced search
Publication Cover
Statistics in Biopharmaceutical Research Volume 15, 2023 - Issue 2
Submit an article Journal homepage
956
Views
28
CrossRef citations to date
0
Altmetric
Special Section: Estimands, Design and Analysis of Clinical Trials with Time-to-Event Outcomes

Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group

Satrajit Roychoudhurya Pfizer Inc., New York, NYCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0003-4001-3036
ORCID Icon,
Keaven M Andersonb Merck and Co, Inc., North Wales, PA
,
Jiabu Yec Astrazeneca Pharmaceuticals, Gaithersburg, MD
&
Pralay Mukhopadhyayd Otsuka America Pharmaceuticals, Inc., Rockville, MD
Pages 280-294 | Received 03 Mar 2020, Accepted 06 Jan 2021, Published online: 04 Mar 2021

Citations (28)

Keep up to date with the latest research on this topic with citation updates for this article.

Subscribe to citation updates

Read on this site (8)

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.
Read now
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.
Read now
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.
Read now
Yuan-Li Shen, Xin Wang, Mushti Sirisha, Flora Mulkey, Jiaxi Zhou, Xin Gao, Lijun Zhang, Thomas Gwise, Shenghui Tang, Marc Theoret, Richard Pazdur & Rajeshwari Sridhara. (2023) Nonproportional Hazards—An Evaluation of the MaxCombo Test in Cancer Clinical Trials. Statistics in Biopharmaceutical Research 15:2, pages 300-309.
Read now
Madan G. Kundu. (2023) Closed-Form Approximation of Correlation Matrix Among Fleming Harrington Test Statistics in MaxCombo Test: Comments on “Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group”. Statistics in Biopharmaceutical Research 15:2, pages 340-342.
Read now
Steven Snapinn, Qi Jiang & Chunlei Ke. (2023) Comment on “Robust Design and Analysis of Clinical Trials With Nonproportional Hazards: A Straw Man Guidance From a Cross-Pharma Working Group”: The Test Statistic Should Estimate Some Reasonable Measure of Treatment Benefit. Statistics in Biopharmaceutical Research 15:2, pages 297-299.
Read now
Dominic Magirr & Carl-Fredrik Burman. (2023) The Strong Null Hypothesis and the MaxCombo Test: Comment on “Robust Design and Analysis of Clinical Trials with Nonproportional Hazards: A Straw Man Guidance form a Cross-Pharma Working Group.”. Statistics in Biopharmaceutical Research 15:2, pages 295-296.
Read now
Zihan Lin, Dan Zhao, Junjing Lin, Ai Ni & Jianchang Lin. (2022) Statistical methods of indirect comparison with real-world data for survival endpoint under non-proportional hazards. Journal of Biopharmaceutical Statistics 32:4, pages 582-599.
Read now

Articles from other publishers (20)

Qingyang Zhang. (2023) A nonparametric test for comparing survival functions based on restricted distance correlation. Dependence Modeling 11:1.
Crossref
Xiaofei Wang & Stephen L George. (2023) Futility monitoring for randomized clinical trials with non-proportional hazards: An optimal conditional power approach. Clinical Trials 20:6, pages 603-612.
Crossref
Lucas C. Godoy, Dennis T. Ko, Michael E. Farkouh, Baiju R. Shah & Peter C. Austin. (2023) Dealing With Nonproportional Hazards in Coronary Revascularisation Studies. Canadian Journal of Cardiology 39:11, pages 1651-1660.
Crossref
Yi‐Cheng Tai, Weijing Wang & Martin T. Wells. (2023) Two‐sample inference procedures under nonproportional hazards . Pharmaceutical Statistics 22:6, pages 1016-1030.
Crossref
Jean Marie Boher, Thomas Filleron, Pierre Bunouf & Richard J. Cook. (2023) New late‐emphasis and combination tests based on infimum and supremum logrank statistics with application in oncology trials. Statistics in Medicine 42:12, pages 1981-1994.
Crossref
Ina Dormuth, Tiantian Liu, Jin Xu, Markus Pauly & Marc Ditzhaus. (2023) A comparative study to alternatives to the log-rank test. Contemporary Clinical Trials 128, pages 107165.
Crossref
Miki Horiguchi, Lu Tian & Hajime Uno. (2023) On assessing survival benefit of immunotherapy using long‐term restricted mean survival time. Statistics in Medicine 42:8, pages 1139-1155.
Crossref
Dominic Magirr & José L. Jiménez. (2023) Stratified modestly weighted log‐rank tests in settings with an anticipated delayed separation of survival curves. Biometrical Journal 65:4.
Crossref
Huan Cheng & Jianghua He. (2023) Sample size calculation for the combination test under nonproportional hazards. Biometrical Journal 65:4.
Crossref
Mary M. Ryan & Daniel L. Gillen. (2023) Sequential sampling in prospective observational studies. The Annals of Applied Statistics 17:1.
Crossref
David Salmon & G. J. Melendez-Torres. (2023) Clinical effectiveness reporting of novel cancer drugs in the context of non-proportional hazards: a review of nice single technology appraisals. International Journal of Technology Assessment in Health Care 39:1.
Crossref
John O'Quigley. (2022) Testing for Differences in Survival When Treatment Effects Are Persistent, Decaying, or Delayed. Journal of Clinical Oncology 40:30, pages 3537-3545.
Crossref
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.
Crossref
Mitchell Paukner & Richard Chappell. (2022) Versatile tests for window mean survival time. Statistics in Medicine 41:19, pages 3720-3736.
Crossref
Kaihuan Qian & Xiaohua Zhou. (2022) Weighted Log-Rank Test for Clinical Trials with Delayed Treatment Effect Based on a Novel Hazard Function Family. Mathematics 10:15, pages 2573.
Crossref
Yiming Chen, John Lawrence & Mei‐Ling Ting Lee. (2022) Group sequential design for randomized trials using “first hitting time” model. Statistics in Medicine 41:13, pages 2375-2402.
Crossref
Beat Neuenschwander, Satrajit Roychoudhury, Simon Wandel, Kannan Natarajan & Emmanuel Zuber. (2022) The Predictive Individual Effect for Survival Data. Therapeutic Innovation & Regulatory Science 56:3, pages 492-500.
Crossref
Dominic Magirr & José L Jiménez. (2022) Design and analysis of group-sequential clinical trials based on a modestly weighted log-rank test in anticipation of a delayed separation of survival curves: A practical guidance. Clinical Trials 19:2, pages 201-210.
Crossref
Pranab Ghosh, Robin Ristl, Franz König, Martin Posch, Christopher Jennison, Heiko Götte, Armin Schüler & Cyrus Mehta. (2021) Robust group sequential designs for trials with survival endpoints and delayed response. Biometrical Journal 64:2, pages 343-360.
Crossref
Revathi Ananthakrishnan, Stephanie Green, Alessandro Previtali, Rong Liu, Daniel Li & Michael LaValley. (2021) Critical review of oncology clinical trial design under non-proportional hazards. Critical Reviews in Oncology/Hematology 162, pages 103350.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.