Statistics in biopharmaceutical research

Keyphrases

Publications

volume 16, number 3, 2024

Beibei Guo, Li Wang, Ying Yuan
Treatment Comparisons in Adaptive Platform Trials Adjusting for Temporal Drift. Statistics in biopharmaceutical research 16 (3) (2024)
Guillaume Mulier, Sylvie Chevret, Ruitao Lin, Lucie Biard
Bayesian Optimal Designs for Multi-Arm Multi-Stage Phase II Randomized Clinical Trials with Multiple Endpoints. Statistics in biopharmaceutical research 16 (3) (2024)
Beibei Guo, Li Wang, Ying Yuan
Treatment Comparisons in Adaptive Platform Trials Adjusting for Temporal Drift. Statistics in biopharmaceutical research 16 (3) (2024)
Beibei Guo, Li Wang, Ying Yuan
Treatment Comparisons in Adaptive Platform Trials Adjusting for Temporal Drift. Statistics in biopharmaceutical research 16 (3) (2024)

volume 15, number 4, 2023

Jonathan Beall, Jordan Elm, James Chamberlain, Eric Rosenthal, Jaideep Kapur, Valerie Durkalski-Mauldin
An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial. Statistics in biopharmaceutical research 15 (4) (2023)
Jonathan Beall, Jordan Elm, James Chamberlain, Eric Rosenthal, Jaideep Kapur, Valerie Durkalski-Mauldin
An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial. Statistics in biopharmaceutical research 15 (4) (2023)
Jonathan Beall, Jordan Elm, James Chamberlain, Eric Rosenthal, Jaideep Kapur, Valerie Durkalski-Mauldin
An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial. Statistics in biopharmaceutical research 15 (4) (2023)
Jonathan Beall, Jordan Elm, James Chamberlain, Eric Rosenthal, Jaideep Kapur, Valerie Durkalski-Mauldin
An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial. Statistics in biopharmaceutical research 15 (4) (2023)

volume 15, number 2, 2022

Camila Olarte Parra, Rhian M Daniel, Jonathan W Bartlett
Hypothetical Estimands in Clinical Trials: A Unification of Causal Inference and Missing Data Methods. Statistics in biopharmaceutical research 15 (2) (2022)

volume 15, number 3, 2022

L U Mao
Power and Sample Size Calculations for the Restricted Mean Time Analysis of Prioritized Composite Endpoints. Statistics in biopharmaceutical research 15 (3) (2022)

volume 14, number 3, 2022

Rong Liu, Ying Yuan, Suman Sen, Xin Yang, Qi Jiang, Xiaoyun Nicole Li, Chengxing Cindy Lu, Mithat Göneng, Hong Tian, Heng Zhou, Ruitao Lin, Olga Marchenko
Accuracy and Safety of Novel Designs for Phase I Drug-Combination Oncology Trials. Statistics in biopharmaceutical research 14 (3) (2022)

volume 14, number 4, 2022

Wenlin Yuan, Ming-Hui Chen, John Zhong
Bayesian Design of Superiority Trials: Methods and Applications. Statistics in biopharmaceutical research 14 (4) (2022)
Wenlin Yuan, Ming-Hui Chen, John Zhong
Bayesian Design of Superiority Trials: Methods and Applications. Statistics in biopharmaceutical research 14 (4) (2022)
Ying Lu, Qian Zhao, Jiying Zou, Shiyan Yan, John S Tamaresis, Lorene Nelson, Xin M Tu, Jie Chen, Lu Tian
A Composite Endpoint for Treatment Benefit According to Patient Preference. Statistics in biopharmaceutical research 14 (4) (2022)
Wenlin Yuan, Ming-Hui Chen, John Zhong
Bayesian Design of Superiority Trials: Methods and Applications. Statistics in biopharmaceutical research 14 (4) (2022)

volume 15, number 1, 2021

Fengming Tang, Byron J Gajewski
Comparative Effectiveness Research using Bayesian Adaptive Designs for Rare Diseases: Response Adaptive Randomization Reusing Participants. Statistics in biopharmaceutical research 15 (1) (2021)
Fengming Tang, Byron J Gajewski
Comparative Effectiveness Research using Bayesian Adaptive Designs for Rare Diseases: Response Adaptive Randomization Reusing Participants. Statistics in biopharmaceutical research 15 (1) (2021)

volume 14, number 1, 2021

Gianna McMillan, Cristiana Mayer, Rui Tang, Yi Liu, Lisa LaVange, Zoran Antonijevic, Robert A Beckman
Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow. Statistics in biopharmaceutical research 14 (1) (2021)
Rob Johnson, Chris Jackson, Anne Presanis, Sofia S Villar, Daniela De Angelis
Quantifying Efficiency Gains of Innovative Designs of Two-Arm Vaccine Trials for COVID-19 Using an Epidemic Simulation Model. Statistics in biopharmaceutical research 14 (1) (2021)

volume 14, number 4, 2021

Lily Zhang, Peter B Gilbert, Edmund Capparelli, Yunda Huang
Simulation-Based Pharmacokinetics Sampling Design for Evaluating Correlates of Prevention Efficacy of Passive HIV Monoclonal Antibody Prophylaxis. Statistics in biopharmaceutical research 14 (4) (2021)
Lily Zhang, Peter B Gilbert, Edmund Capparelli, Yunda Huang
Simulation-Based Pharmacokinetics Sampling Design for Evaluating Correlates of Prevention Efficacy of Passive HIV Monoclonal Antibody Prophylaxis. Statistics in biopharmaceutical research 14 (4) (2021)
Zheyu Wang, Fujun Wang, Chenguang Wang, Jianliang Zhang, Hao Wang, Li Shi, Zhuojun Tang, Gary L Rosner
A Bayesian decision-theoretic design for simultaneous biomarker-based subgroup selection and efficacy evaluation. Statistics in biopharmaceutical research 14 (4) (2021)
Lily Zhang, Peter B Gilbert, Edmund Capparelli, Yunda Huang
Simulation-Based Pharmacokinetics Sampling Design for Evaluating Correlates of Prevention Efficacy of Passive HIV Monoclonal Antibody Prophylaxis. Statistics in biopharmaceutical research 14 (4) (2021)
Zheyu Wang, Fujun Wang, Chenguang Wang, Jianliang Zhang, Hao Wang, Li Shi, Zhuojun Tang, Gary L Rosner
A Bayesian decision-theoretic design for simultaneous biomarker-based subgroup selection and efficacy evaluation. Statistics in biopharmaceutical research 14 (4) (2021)
Zheyu Wang, Fujun Wang, Chenguang Wang, Jianliang Zhang, Hao Wang, Li Shi, Zhuojun Tang, Gary L Rosner
A Bayesian decision-theoretic design for simultaneous biomarker-based subgroup selection and efficacy evaluation. Statistics in biopharmaceutical research 14 (4) (2021)

volume 13, number 3, 2021

Lu Mao, KyungMann Kim
Statistical models for composite endpoints of death and non-fatal events: a review. Statistics in biopharmaceutical research 13 (3) (2021)
Weiji Su, Emrah Gecili, Xia Wang, Rhonda D Szczesniak
An empirical comparison of segmented and stochastic linear mixed effects models to estimate rapid disease progression in longitudinal biomarker studies. Statistics in biopharmaceutical research 13 (3) (2021)

volume 14, number 1, 2020

Tianyu Zhan, Alan Hartford, Jian Kang, Walter Offen
Optimizing Graphical Procedures for Multiplicity Control in a Confirmatory Clinical Trial via Deep Learning. Statistics in biopharmaceutical research 14 (1) (2020)

volume 14, number 2, 2020

Biyue Dai, Mei-Yin C Polley
Two-Stage Adaptive Design for Prognostic Biomarker Signatures with a Survival Endpoint. Statistics in biopharmaceutical research 14 (2) (2020)
Guoqing Diao, Guanghan F Liu, Donglin Zeng, Yilong Zhang, Gregory Golm, Joseph F Heyse, Joseph G Ibrahim
Efficient Multiple Imputation for Sensitivity Analysis of Recurrent Events Data with Informative Censoring. Statistics in biopharmaceutical research 14 (2) (2020)

volume 13, number 2, 2020

Ying Lu, Lu Tian
Statistical Considerations for Sequential Analysis of the Restricted Mean Survival Time for Randomized Clinical Trials. Statistics in biopharmaceutical research 13 (2) (2020)
Yanhong Zhou, Ruobing Li, Fangrong Yan, J Jack Lee, Ying Yuan
A comparative study of Bayesian optimal interval (BOIN) design with interval 3+3 (i3+3) design for phase I oncology dose-finding trials. Statistics in biopharmaceutical research 13 (2) (2020)

volume 13, number 4, 2020

Guogen Shan, Ece Bayram, Jessica Z K Caldwell, Justin B Miller, Jay J Shen, Shawn Gerstenberger
Partial correlation coefficient for a study with repeated measurements. Statistics in biopharmaceutical research 13 (4) (2020)

volume 12, number 3, 2020

Lili Zhao, Sunghun Lee, Rongxia Li, Edison Ong, Yongqun He, Gary Freed
Improvement in the Analysis of Vaccine Adverse Event Reporting System Database. Statistics in biopharmaceutical research 12 (3) (2020)

volume 12, number 4, 2020

Evgeny Degtyarev, Kaspar Rufibach, Yue Shentu, Godwin Yung, Michelle Casey, Stefan Englert, Feng Liu, Yi Liu, Oliver Sailer, Jonathan Siegel, Steven Sun, Rui Tang, Jiangxiu Zhou, null null
Assessing the Impact of COVID-19 on the Clinical Trial Objective and Analysis of Oncology Clinical Trials-Application of the Estimand Framework. Statistics in biopharmaceutical research 12 (4) (2020)
Jonathan W Bartlett, Tim P Morris, Mats J Stensrud, Rhian M Daniel, Stijn K Vansteelandt, Carl-Fredrik Burman
The Hazards of Period Specific and Weighted Hazard Ratios. Statistics in biopharmaceutical research 12 (4) (2020)
William R Zame, Ioana Bica, Cong Shen, Alicia Curth, Hyun-Suk Lee, Stuart Bailey, James Weatherall, David Wright, Frank Bretz, Mihaela van der Schaar
Machine learning for clinical trials in the era of COVID-19. Statistics in biopharmaceutical research 12 (4) (2020)
Tong Guo, Chian Chen, Chieh Chiang, Chi-Tian Chen, Chin-Fu Hsiao
Operational Experiences in China and Statistical Issues on the Conduct of Clinical Trials During the COVID-19 Pandemic. Statistics in biopharmaceutical research 12 (4) (2020)
Ray S Lin, Ji Lin, Satrajit Roychoudhury, Keaven M Anderson, Tianle Hu, Bo Huang, Larry F Leon, Jason J Z Liao, Rong Liu, Xiaodong Luo, Pralay Mukhopadhyay, Rui Qin, Kay Tatsuoka, Xuejing Wang, Yang Wang, Jian Zhu, Tai-Tsang Chen, Renee Iacona, null null
Rejoinder to Letter to the Editor "The Hazards of Period Specific and Weighted Hazard Ratios". Statistics in biopharmaceutical research 12 (4) (2020)
R Daniel Meyer, Bohdana Ratitch, Marcel Wolbers, Olga Marchenko, Hui Quan, Daniel Li, Christine Fletcher, Xin Li, David Wright, Yue Shentu, Stefan Englert, Wei Shen, Jyotirmoy Dey, Thomas Liu, Ming Zhou, Norman Bohidar, Peng-Liang Zhao, Michael Hale
Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic. Statistics in biopharmaceutical research 12 (4) (2020)
Cornelia Ursula Kunz, Silke Jörgens, Frank Bretz, Nigel Stallard, Kelly Van Lancker, Dong Xi, Sarah Zohar, Christoph Gerlinger, Tim Friede
Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue? Statistics in biopharmaceutical research 12 (4) (2020)
Brian L Wiens, Ilya Lipkovich
The Impact of Major Events on Ongoing Noninferiority Trials, With Application to COVID-19. Statistics in biopharmaceutical research 12 (4) (2020)
Sylva H Collins, Mark S Levenson
Comment on "Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic". Statistics in biopharmaceutical research 12 (4) (2020)
Michael O'Kelly, Siying Li
Assessing via Simulation the Operating Characteristics of the WHO Scale for COVID-19 Endpoints. Statistics in biopharmaceutical research 12 (4) (2020)
Rob Hemmings
Under a Black Cloud Glimpsing a Silver Lining: Comment on Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic. Statistics in biopharmaceutical research 12 (4) (2020)
Pierre-François Dequin, Amélie Le Gouge, Elsa Tavernier, Bruno Giraudeau, Sarah Zohar
Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience. Statistics in biopharmaceutical research 12 (4) (2020)
Toshimitsu Hamasaki, Frank Bretz, Freda Cooner, Lisa M LaVange, Martin Posch
Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic. Statistics in biopharmaceutical research 12 (4) (2020)
Mary Nilsson, Brenda Crowe, Greg Anglin, Greg Ball, Melvin Munsaka, Seta Shahin, Wei Wang
Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19. Statistics in biopharmaceutical research 12 (4) (2020)
Mouna Akacha, Janice Branson, Frank Bretz, Bharani Dharan, Paul Gallo, Insa Gathmann, Robert Hemmings, Julie Jones, Dong Xi, Emmanuel Zuber
Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials. Statistics in biopharmaceutical research 12 (4) (2020)
Nigel Stallard, Lisa Hampson, Norbert Benda, Werner Brannath, Thomas Burnett, Tim Friede, Peter K Kimani, Franz Koenig, Johannes Krisam, Pavel Mozgunov, Martin Posch, James M S Wason, Gernot Wassmer, John Whitehead, S Faye Williamson, Sarah Zohar, Thomas F Jaki
Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19. Statistics in biopharmaceutical research 12 (4) (2020)