Journal of biopharmaceutical statistics

Keyphrases

Publications

2024

Hou-Cheng Yang, Guanyu Hu
Bayesian spatial cluster signal learning with application to adverse event (AE). Journal of biopharmaceutical statistics (2024)
Xi Chen, Ying Zhang, Amanda M Fretts, Tauqeer Ali, Jason G Umans, Richard B Devereux, Elisa T Lee, Shelley A Cole, Yan Daniel Zhao
Assessing the use of GEE methods for analyzing binary outcomes in family studies: the Strong Heart Family Study. Journal of biopharmaceutical statistics (2024)
Shein-Chung Chow, Peijin Wang
On the use of RWD in support of regulatory submission in drug development. Journal of biopharmaceutical statistics (2024)
Shibing Deng, Shein-Chung Chow
Empower clinical development by harnessing data from diverse sources: methodology, applications and regulatory perspectives. Journal of biopharmaceutical statistics (2024)
Xiner Zhou, Herbert H Pang, Christiana Drake, Hans Ulrich Burger, Jiawen Zhu
Estimating treatment effect in randomized trial after control to treatment crossover using external controls. Journal of biopharmaceutical statistics (2024)
Junjing Lin, Jianchang Lin
Incorporating external real-world data (RWD) in confirmatory adaptive design. Journal of biopharmaceutical statistics (2024)
Runjia Li, Liwen Wu, Rachael Liu, Jianchang Lin
Flexible seamless 2-in-1 design with sample size adaptation. Journal of biopharmaceutical statistics (2024)
Kai Chen, Yunqi Zhao, Meizi Liu, Jianchang Lin, Rachael Liu
DOD-Combo: Bayesian dose finding design in combination trials with meta-analytic-predictive prior. Journal of biopharmaceutical statistics (2024)
Yifan Zhou, Abigail Sloan, Sandeep Menon, Ling Wang
Combination MCP-Mod for two-drug combination dose-ranging studies. Journal of biopharmaceutical statistics (2024)
Moumita Chatterjee, Sugata Sen Roy, Bhaswati Ganguli
Modelling alternately recurring events using subject specific hazard estimation approach. Journal of biopharmaceutical statistics (2024)
Dasom Lee, Shu Yang, Mark Berry, Tom Stinchcombe, Harvey Jay Cohen, Xiaofei Wang
genRCT: a statistical analysis framework for generalizing RCT findings to real-world population. Journal of biopharmaceutical statistics (2024)
Xiaohan Guo, Sean Kent, Arnab Maity, Wei Zhong
Optimization of EWOC principle in BLRM design for phase 1 oncology trials. Journal of biopharmaceutical statistics (2024)
Gang Li, Hui Quan, Yining Wang
Regional consistency assessment in multiregional clinical trials. Journal of biopharmaceutical statistics (2024)
Bradley Hupf, Yunlong Yang, Ryan Gryder, Veronica Bunn, Jianchang Lin
Covariate adjusted meta-analytic predictive (CA-MAP) prior for historical borrowing using patient-level data. Journal of biopharmaceutical statistics (2024)
Peijin Wang, Shein-Chung Chow
The use of real-world data for clinical investigation of effectiveness in drug development. Journal of biopharmaceutical statistics (2024)
Zahra Rezaei Ghahroodi, Samaneh Eftekhari Mahabadi, Alireza Esberizi, Ramin Sami, Marjan Mansourian
Association of the medication protocols and longitudinal change of COVID-19 symptoms: a hospital-based mixed-statistical methods study. Journal of biopharmaceutical statistics (2024)
Kentaro Takeda, Atsuki Hashimoto, Shufang Liu, Alan Rong
A basket trial design based on constrained hierarchical Bayesian model for latent subgroups. Journal of biopharmaceutical statistics (2024)
Meihua Long, Jiali Song, Zhiwei Rong, Lan Mi, Yuqin Song, Yan Hou
Adaptively leverage multiple real-world data sources for treatment effect estimation based on similarity. Journal of biopharmaceutical statistics (2024)
John Devin Peipert, Monique Breslin, Ethan Basch, Melanie Calvert, David Cella, Mary Lou Smith, Gita Thanarajasingam, Jessica Roydhouse
[Special issue PRO] Considering endpoints for comparative tolerability of cancer treatments using patient report given the estimand framework. Journal of biopharmaceutical statistics (2024)
Lysbeth Floden, Michael DeRosa, Jessica Roydhouse, Jennifer L Beaumont, Stacie Hudgens
[Special issue PRO] A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes. Journal of biopharmaceutical statistics (2024)
Antonio Martín Andrés, Francisco Gayá Moreno, María Álvarez Hernández, Inmaculada Herranz Tejedor
Miettinen and Nurminen score statistics revisited. Journal of biopharmaceutical statistics (2024)
Jiwei He, Di Zhang, Feng Li
Statistical methods to control for confounders in rare disease settings that use external control. Journal of biopharmaceutical statistics (2024)
Ramin B Arani, Jessie Wang, Dong Pang, Samriddhi Buxy Sinha, Martina Uttenreuther-Fischer, Shein-Chung Chow
Utility of real-world evidence in biosimilar development. Journal of biopharmaceutical statistics (2024)
Derek Dinart, Jean-Yves Blay, Virginie Rondeau
Sample size estimation for recurrent event data using multifrailty and multilevel survival models. Journal of biopharmaceutical statistics (2024)
Kejia Wang, Chang-Xing Ma
Interval estimation of relative risks for combined unilateral and bilateral correlated data. Journal of biopharmaceutical statistics (2024)
Haidy A Newer
P-values and confidence intervals for weighted log-rank tests under truncated binomial design based on clustered medical data. Journal of biopharmaceutical statistics (2024)
Hani Samawi, Jing Kersey, Jingjing Yin, Haresh Rochani
Medical diagnostic accuracy measures: an innovative approach based on the area under predictive values curves. Journal of biopharmaceutical statistics (2024)
Javier Cabrera, Birol Emir, Ge Cheng, Yajie Duan, Demissie Alemayehu, Yauheniya Cherkas
An enriched approach to combining high-dimensional genomic and low-dimensional phenotypic data. Journal of biopharmaceutical statistics (2024)
Bosheng Li, Fangrong Yan, Depeng Jiang
Adaptive promising zone design for cancer immunotherapy with heterogeneous delayed treatment effect. Journal of biopharmaceutical statistics (2024)
Meihua Long, Jiali Song, Zhiwei Rong, Lan Mi, Yuqin Song, Yan Hou
Adaptively leverage multiple real-world data sources for treatment effect estimation based on similarity. Journal of biopharmaceutical statistics (2024)
Xiaohan Guo, Sean Kent, Arnab Maity, Wei Zhong
Optimization of EWOC principle in BLRM design for phase 1 oncology trials. Journal of biopharmaceutical statistics (2024)
Xiaofeng Tina Wang, Paul Schuette, Matilde Kam
FDA experiences with a centralized statistical monitoring tool. Journal of biopharmaceutical statistics (2024)
Ping Gao, Weidong Zhang
Adaptive sequential design for phase II single-arm oncology trials: an expansion of Simon's design. Journal of biopharmaceutical statistics (2024)
Shibing Deng, Feng Liu, Jadwiga Bienkowska
Assessing clinical response in early oncology development with a predictive biomarker. Journal of biopharmaceutical statistics (2024)
Dasom Lee, Chenyin Gao, Sujit Ghosh, Shu Yang
Transporting survival of an HIV clinical trial to the external target populations. Journal of biopharmaceutical statistics (2024)
Weijia Mai, Shein-Chung Chow
Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift. Journal of biopharmaceutical statistics (2024)
Liang Tong, Chen Li, Jielai Xia, Ling Wang
A Bayesian approach based on discounting factor for consistency assessment in multi-regional clinical trial. Journal of biopharmaceutical statistics (2024)
Liang Tong, Chen Li, Jielai Xia, Ling Wang
A Bayesian approach based on discounting factor for consistency assessment in multi-regional clinical trial. Journal of biopharmaceutical statistics (2024)
Gerasimos Dumi, Dara O'Neill, Christina Daskalopoulou, Tom Keeley, Stephanie Rhoten, Dharmraj Sauriyal, Piper Fromy
The impact of different data handling strategies in exploratory and confirmatory factor analysis of diary measures: an evaluation using simulated and real-world asthma nighttime symptoms diary data. Journal of biopharmaceutical statistics (2024)
Jun Wang, Jie Chen, Jun Zhao, Ying Wu, Xiaona Xin, Pingyan Chen
Establishment of RWS guidance reflecting contributions of China to regulatory science. Journal of biopharmaceutical statistics (2024)
Xinxin Chen, Brady Nifong, Ethan M Alt, Matthew A Psioda, Joseph G Ibrahim
Bayesian design of clinical trials using the scale transformed power prior. Journal of biopharmaceutical statistics (2024)
Gerasimos Dumi, Dara O'Neill, Christina Daskalopoulou, Tom Keeley, Stephanie Rhoten, Dharmraj Sauriyal, Piper Fromy
The impact of different data handling strategies in exploratory and confirmatory factor analysis of diary measures: an evaluation using simulated and real-world asthma nighttime symptoms diary data. Journal of biopharmaceutical statistics (2024)
Jie Chen, Xiaoyun Nicole Li, Chengxing Cindy Lu, Sammy Yuan, Godwin Yung, Jingjing Ye, Hong Tian, Jianchang Lin
Considerations for master protocols using external controls. Journal of biopharmaceutical statistics (2024)
Miao Zang, Rui Liu
Generalized triple outcome decision-making in basket trials. Journal of biopharmaceutical statistics (2024)
Ping Gao, Weidong Zhang
A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics. Journal of biopharmaceutical statistics (2024)
Ping Gao, Yingqiu Li
Adaptive two-stage seamless sequential design for clinical trials. Journal of biopharmaceutical statistics (2024)
Jiwei He, Di Zhang, Feng Li
Statistical methods to control for confounders in rare disease settings that use external control. Journal of biopharmaceutical statistics (2024)
Liwen Wu, Jianchang Lin
An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment. Journal of biopharmaceutical statistics (2024)
Shuman Sun, Zhiming Li, Keyi Mou
Interval estimation of common risk difference for stratified unilateral and bilateral data✩. Journal of biopharmaceutical statistics (2024)

volume 34, number 5, 2024

Ping Gao, Weidong Zhang
A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics. Journal of biopharmaceutical statistics 34 (5) (2024)