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Research Article

Article
Trial Design with Win Statistics for Multiple Time-to-Event Endpoints with Hierarchy
Huiman X. Barnhart, Yuliya Lokhnygina, Roland A. Matsouaka & Frank W. Rockhold
Published online: 15 Jul 2024
  • 83 Views
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Research Article

Article
Unsupervised Imputation of Non-Ignorably Missing Data Using Importance-Weighted Autoencoders
David K. Lim, Naim U. Rashid, Junier B. Oliva & Joseph G. Ibrahim
Published online: 15 Jul 2024
  • 29 Views
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Comment

Comment
Comb-BOIN12: A Utility-Based Bayesian Optimal Interval Design for Dose Optimization in Cancer Drug-Combination Trials
Mengyi Lu, Jingyi Zhang, Ying Yuan & Ruitao Lin
Accepted author version posted online: 26 Jun 2024
  • 48 Views
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Research Article

Article
Possible data-generating models of longitudinal continuous outcomes and intercurrent events to investigate estimands
Marian Mitroiu, Steven Teerenstra, Katrien Oude Rengerink, Frank Pétavy & Kit CB Roes
Accepted author version posted online: 26 Jun 2024
  • 318 Views
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Open Access

Research Article

Article
A statistical method for protocol modifications with heterogeneous population variances
Chieh Chiang, Yuh-Jenn Wu, Li-Hsueh Cheng, Ching-Ti Liu & Chin-Fu Hsiao
Accepted author version posted online: 26 Jun 2024
  • 6 Views
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Research Article

Article
MT-Keyboard: A Bayesian Model-assisted Interval Design to Account for Toxicity Grades and Types for Phase I Trials
Kai Chen, Li Wang & Ying Yuan
Accepted author version posted online: 26 Jun 2024
  • 17 Views
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Research Article

Article
Establishing and using threshold of surrogate endpoint in relation to clinical endpoint#
Yu-Chieh Cheng, Hsiao-Hui Tsou, H.M.James Hung, Byron Fan & Brandon Fan
Accepted author version posted online: 21 Jun 2024
  • 21 Views
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Research Article

Article
Eliciting the discount parameter in a power prior method on the basis of the type I error consideration
Se Yoon Lee
Accepted author version posted online: 17 Jun 2024
  • 124 Views
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Research Article

Article
U-MET: Utility-Based Dose Optimization Approach for Multiple-Dose Randomized Trial Designs
Gina D’Angelo, Maozhen Gong, Jayne Marshall, Ying Yuan & Xia Li
Accepted author version posted online: 11 Jun 2024
  • 75 Views
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Discussion

Discussion
Monitoring overall survival in pivotal trials in indolent cancers
Thomas R Fleming, Lisa V Hampson, Bharani-Dharan Bharani, Frank Bretz, Arunava Chakravartty, Thibaud Coroller, Evanthia Koukouli, Janet Wittes, Nigel Yateman & Emmanuel Zuber
Accepted author version posted online: 10 Jun 2024
  • 53 Views
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Research Article

Article
Beyond the Classical Type I Error: Bayesian Metrics for Bayesian Designs Using Informative Priors
Nicky Best, Maxine Ajimi, Beat Neuenschwander, Gaëlle Saint-Hilary, Simon Wandel & on behalf of the PSI/EFSPI special interest group “Historical Data”
Published online: 31 May 2024
  • 1307 Views
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Open Access

Research Article

Article
Bayesian Optimal Designs for Multi-Arm Multi-Stage Phase II Randomized Clinical Trials with Multiple Endpoints
Guillaume Mulier, Sylvie Chevret, Ruitao Lin & Lucie Biard
Published online: 17 May 2024
  • 324 Views
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Open Access

Research Article

Article
Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective
Rong Liu, Ying Yuan, Suman Sen, Olga Marchenko, Qi Jiang, Hong Tian, Xiaoyun Li, Ruitao Lin, Cindy Lu & Heng Zhou
Published online: 14 May 2024
  • 363 Views
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Research Article

Article
Some Group Sequential Trials from Industry over the Last 30 Years
Keaven M. Anderson, Yujie Zhao, Nan Xiao, Joy Ge & Harlan F. Weisman
Published online: 08 May 2024
  • 105 Views
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Research Article

Article
Restricted Time Win Ratio: From Estimands to Estimation
Tuo Wang, Ying Li & Yongming Qu
Published online: 26 Apr 2024
  • 134 Views
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Research Article

Article
Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes
Helen Barnett, Oliver Boix, Dimitris Kontos & Thomas Jaki
Published online: 17 Apr 2024
  • 397 Views
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Open Access

Research Article

Article
Monitoring Ongoing Clinical Trials Under Fractional Brownian Motion With Drift
Peng Zhang, Weichung Joe Shih, Yong Lin, K. K. Gordon Lan & Tai Xie
Published online: 15 Apr 2024
  • 108 Views
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Research Article

Article
An Instrumental Variable Approach to Learning the Causal Exposure–Response Relationship in a Randomized Dose Comparison Trial
Zhiwei Zhang, Jixian Wang & Dong Xi
Published online: 12 Apr 2024
  • 67 Views
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Research Article

Article
Implementation of Statistical Innovation in a Pharmaceutical Company
Kaspar Rufibach, Marcel Wolbers, Jenny Devenport, Godwin Yung, Chris Harbron, Alun Bedding, Zhiyue Huang, Ray Lin, Herbert Pang, Daniel Sabanés Bové & Jianmei Wang
Published online: 11 Apr 2024
  • 666 Views
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Research Article

Article
Bayesian and Frequentist Approaches to Rescuing Disrupted Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions
Cornelia Ursula Kunz, Sergey Tarima, Gary L. Rosner, Richard Emsley, Madeline Bauer, Christopher Jennison, James L. Rosenberger, Nigel Stallard, Sarah Zohar & Nancy Flournoy
Published online: 19 Mar 2024
  • 575 Views
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Open Access

Research Article

Article
Optimizing Patient Recruitment in Global Clinical Trials using Nature-Inspired Metaheuristics
Mitchell Aaron Schepps, Weng Kee Wong, Matt Austin & Volodymyr Anisimov
Published online: 18 Mar 2024
  • 757 Views
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Open Access

Research Article

Article
A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design
Li Yang, Guoqing Diao & William F. Rosenberger
Published online: 26 Feb 2024
  • 161 Views
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Research Article

Article
Dose Optimization for Novel Oncology Agents: Design Options and Strategies
David Dejardin, Bo Huang, Ying Yuan, Ulrich Beyer, Jane Fridlyand & Jiawen Zhu
Published online: 26 Feb 2024
  • 264 Views
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Research Article

Article
Estimands in Oncology Early Clinical Development: Assessing the Impact of Intercurrent Events on the Dose-Toxicity Relationship
Francois Mercier, Victoria Homer, Junxian Geng, Hongtao Zhang, Stefan Englert, Natalia Kan-Dobrosky & Anja Victor
Published online: 18 Dec 2023
  • 298 Views
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Research Article

Article
Effects of Allocation Method and Time Trends on Identification of the Best Arm in Multi-Arm Trials
Lindsay R. Berry, Elizabeth Lorenzi, Nicholas S. Berry, Amy M. Crawford, Peter Jacko & Kert Viele
Published online: 02 Jan 2024
  • 113 Views
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Research Article

Article
Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing
Jennifer L. Proper, Veronica Bunn, Bradley Hupf & Jianchang Lin
Published online: 12 Dec 2023
  • 316 Views
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Research Article

Article
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials
Ziji Yu, Yanzhao Wang & Jianchang Lin
Published online: 07 Dec 2023
  • 207 Views
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Research Article

Article
Conditional and Unconditional Treatment Effects in Randomized Clinical Trials: Estimands, Estimation, and Interpretation
Jiawei Wei, Jiajun Xu, Björn Bornkamp, Ray Lin, Hong Tian, Dong Xi, Xin Zhang, Ziqiang Zhao & Satrajit Roychoudhury
Published online: 12 Dec 2023
  • 700 Views
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Research Article

Article
Treatment Comparisons in Adaptive Platform Trials Adjusting for Temporal Drift
Beibei Guo, Li Wang & Ying Yuan
Published online: 11 Dec 2023
  • 116 Views
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Research Article

Article
Joint Analysis of Longitudinal Ordinal Categorical Item Response Data and Survival Times with Cure Fraction
Ming Chi, Xiaogang Wang, Hui Song, Yingwei Peng & Dongsheng Tu
Published online: 30 Nov 2023
  • 134 Views
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Research Article

Article
Adjusting for Time-Varying Treatment Switches in Randomized Clinical Trials: The Danger of Extrapolation and How to Address It
Hege Michiels, An Vandebosch & Stijn Vansteelandt
Published online: 29 Nov 2023
  • 261 Views
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Research Article

Article
Weighted Hazard Ratio Estimation for Delayed and Diminishing Treatment Effect
Bharati Kumar & Jonathan W. Bartlett
Published online: 05 Jan 2024
  • 533 Views
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Open Access

Research Article

Article
Isotonic Phase I Cancer Clinical Trial Design Utilizing Patient-Reported Outcomes
Nolan A. Wages & Ruitao Lin
Published online: 28 Nov 2023
  • 71 Views
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Research Article

Article
A Method for Ensuring a Consistent Dose–Response Relationship Between An Entire Population and One Region in Multiregional Dose–Response Studies Using MCP-Mod
Shuhei Kaneko
Published online: 31 Oct 2023
  • 143 Views
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Research Article

Article
Validity of Tests for Time-to-Event Endpoints in Studies with the Pocock and Simon Covariate-Adaptive Randomization
Victoria P. Johnson, Michael Gekhtman & Olga M. Kuznetsova
Published online: 25 Sep 2023
  • 110 Views
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Research Article

Article
Nonconcurrent Controls in Platform Trials: Can We Borrow Their Concurrent Observation Data?
Ziren Jiang, Chengxing (Cindy) Lu, Jialing Liu, Satrajit Roychoudhury, Daniel Meyer, Bo Huang & Haitao Chu
Published online: 05 Oct 2023
  • 201 Views
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Research Article

Article
Covariate-Adaptive Biased Coin Randomization for Master Protocols with Multiple Interventions and Biomarker-Stratified Allocation
Tianhao Song, Lisa M. LaVange & Anastasia Ivanova
Published online: 09 Oct 2023
  • 70 Views
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Research Article

Article
Generalized Likelihood Ratios for Designing Dose Optimization Studies of Targeted Therapies
Zhiwei Zhang & Yan Li
Published online: 05 Oct 2023
  • 61 Views
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Research Article

Article
Using Randomization Tests to Address Disruptions in Clinical Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions
Diane Uschner, Oleksandr Sverdlov, Kerstine Carter, Jonathan Chipman, Olga Kuznetsova, Jone Renteria, Adam Lane, Chris Barker, Nancy Geller, Michael Proschan, Martin Posch, Sergey Tarima, Frank Bretz & William F. Rosenberger
Published online: 18 Oct 2023
  • 963 Views
  • 1 CrossRef citations
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Open Access

Research Article

Article
A Randomization-Based Theory for Preliminary Testing of Covariate Balance in Controlled Trials
Anqi Zhao & Peng Ding
Published online: 13 Oct 2023
  • 89 Views
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Research Article

Article
Balancing the Objectives of Statistical Efficiency and Allocation Randomness in Randomized Controlled Trials
Oleksandr Sverdlov & Yevgen Ryeznik
Published online: 20 Sep 2023
  • 359 Views
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Research Article

Article
Randomization-Based Inference for Clinical Trials with Missing Outcome Data
Nicole Heussen, Ralf-Dieter Hilgers, William F. Rosenberger, Xiao Tan & Diane Uschner
Published online: 27 Sep 2023
  • 161 Views
  • 1 CrossRef citations
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Research Article

Article
Statistical Inference for Vaccine Efficacy: A Re-Randomization Procedure to Analyse Poisson Outcomes under Covariate-Adaptive Randomization
Leroy Jide Ovbude, Luca Grassano, Brigitte Cheuvart & Francesca Solmi
Published online: 24 Aug 2023
  • 893 Views
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Open Access

Research Article

Article
Regulatory Guidance on Randomization and the Use of Randomization Tests in Clinical Trials: A Systematic Review
Kerstine Carter, Annika L. Scheffold, Jone Renteria, Vance W. Berger, Yuqun Abigail Luo, Jonathan J. Chipman & Oleksandr Sverdlov
Published online: 15 Aug 2023
  • 1385 Views
  • 1 CrossRef citations
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Open Access

Research Article

Article
Which Randomization Methods Are Used Most Frequently in Clinical Trials? Results of a Survey by the Randomization Working Group
Oleksandr Sverdlov, Kerstine Carter, Ralf-Dieter Hilgers, Colin C. Everett, Vance W. Berger, Yuqun Abigail Luo, Jonathan J. Chipman, Yevgen Ryeznik, Jennifer Ross, Ruth Knight & Kazumi Yamada
Published online: 11 Jul 2023
  • 281 Views
  • 1 CrossRef citations
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Research Article

Article
Minimizing Selection Bias Under the Blackwell and Hodges Model with an Equal Allocation Procedure in a Symmetric Allocation Space
Olga M. Kuznetsova
Published online: 02 Jun 2023
  • 52 Views
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