Browse this journal

Latest articles

‘Latest articles’ are articles accepted for publication in this journal but not yet published in a volume/issue. Articles are removed from the ‘Latest articles’ list when they are published in a volume/issue. Latest articles are citable using the author(s), year of online publication, article title, journal and article DOI.

Download Citation Download PDFs

Research Article

Article
A machine learning case study to predict rare clinical event of interest: imbalanced data, interpretability, and practical considerations
Sheng Zhong, Jane Zhang, Jenny Jiao, Hongjian Zhu, Yunzhao Xing & Li Wang
Published online: 11 Jun 2024
  • 0 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Investigating pharmacokinetic profiles of Centella asiatica using machine learning and PBPK modelling
Siriwan Pumkathin, Yuranan Hanlumyuang, Worawat Wattanathana, Teeraphan Laomettachit & Monrudee Liangruksa
Published online: 11 Jun 2024
  • 0 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Saddlepoint p-values for a class of location-scale tests
Abd El-Raheem M. Abd El-Raheem, Haidy N. Mohamed & Ehab F. Abd-Elfattah
Published online: 10 Jun 2024
  • 0 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift
Elena Shergina, Kimber P. Richter, Chuanwu Zhang, Laura Mussulman, Niaman Nazir & Byron J. Gajewski
Published online: 07 Jun 2024
  • 7 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Conditional bias adjusted estimator of treatment effect in 2-in-1 adaptive design
Xiaofei Bai, Qiqi Deng & Wen Li
Published online: 06 Jun 2024
  • 14 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Application of estimand framework to the design and analysis of multi-regional clinical trials
Cuizhen Niu, Liwen Liang, Rong Fu, Wenyan Zhong & William W.B. Wang
Published online: 05 Jun 2024
  • 30 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Improved automated spot counting and modeling with bias correction
Chun Pang Lin, Yajie Duan, Davit Sargsyan, Helena Geys, Jocelyn Sendecki, Kanaka Tatikola, Surya Mohanty, Ge Cheng, Mahan Dastgiri & Javier Cabrera
Published online: 05 Jun 2024
  • 22 Views
  • 0 CrossRef citations
  • 0Altmetric

Review Article

Review Article
Biomarker-driven basket trial designs: origins and new methodological developments
Yue Tu & Lindsay A. Renfro
Published online: 04 Jun 2024
  • 26 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
A systematic approach to adaptive sequential design for clinical trials: using simulations to select a design with desired operating characteristics
Ping Gao & Weidong Zhang
Published online: 30 May 2024
  • 199 Views
  • 0 CrossRef citations
  • 0Altmetric
Open Access

Research Article

Article
Adaptive two-stage seamless sequential design for clinical trials
Ping Gao & Yingqiu Li
Published online: 05 May 2024
  • 348 Views
  • 0 CrossRef citations
  • 0Altmetric
Open Access

Research Article

Article
Statistical methods to control for confounders in rare disease settings that use external control
Jiwei He, Di Zhang & Feng Li
Published online: 02 May 2024
  • 215 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
[Special issue PRO] A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes
Lysbeth Floden, Michael DeRosa, Jessica Roydhouse, Jennifer L. Beaumont & Stacie Hudgens
Published online: 30 Apr 2024
  • 56 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
An adaptive seamless 2-in-1 design with biomarker-driven subgroup enrichment
Liwen Wu & Jianchang Lin
Published online: 23 Apr 2024
  • 104 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Bayesian design of clinical trials using the scale transformed power prior
Xinxin Chen, Brady Nifong, Ethan M. Alt, Matthew A. Psioda & Joseph G. Ibrahim
Published online: 19 Apr 2024
  • 79 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Utility of real-world evidence in biosimilar development
Ramin B. Arani, Jessie Wang, Dong Pang, Samriddhi Buxy Sinha, Martina Uttenreuther-Fischer & Shein-Chung Chow
Published online: 17 Apr 2024
  • 77 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Adaptive sequential design for phase II single-arm oncology trials: an expansion of Simon’s design
Ping Gao & Weidong Zhang
Published online: 15 Apr 2024
  • 239 Views
  • 0 CrossRef citations
  • 0Altmetric
Open Access

Research Article

Article
Adaptive promising zone design for cancer immunotherapy with heterogeneous delayed treatment effect
Bosheng Li, Fangrong Yan & Depeng Jiang
Published online: 14 Apr 2024
  • 90 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
P-values and confidence intervals for weighted log-rank tests under truncated binomial design based on clustered medical data
Haidy A. Newer
Published online: 14 Apr 2024
  • 38 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Medical diagnostic accuracy measures: an innovative approach based on the area under predictive values curves
Hani Samawi, Jing Kersey, Jingjing Yin & Haresh Rochani
Published online: 14 Apr 2024
  • 42 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
genRCT: a statistical analysis framework for generalizing RCT findings to real-world population
Dasom Lee, Shu Yang, Mark Berry, Tom Stinchcombe, Harvey Jay Cohen & Xiaofei Wang
Published online: 08 Apr 2024
  • 106 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
An enriched approach to combining high-dimensional genomic and low-dimensional phenotypic data
Javier Cabrera, Birol Emir, Ge Cheng, Yajie Duan, Demissie Alemayehu & Yauheniya Cherkas
Published online: 05 Apr 2024
  • 29 Views
  • 0 CrossRef citations
  • 0Altmetric

Editorial

Editorial
Empower clinical development by harnessing data from diverse sources: methodology, applications and regulatory perspectives
Shibing Deng & Shein-Chung Chow
Published online: 01 Apr 2024
  • 127 Views
  • 0 CrossRef citations
  • 0Altmetric
Free Access

Research Article

Article
Optimization of EWOC principle in BLRM design for phase 1 oncology trials
Xiaohan Guo, Sean Kent, Arnab Maity & Wei Zhong
Published online: 01 Apr 2024
  • 104 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Covariate adjusted meta-analytic predictive (CA-MAP) prior for historical borrowing using patient-level data
Bradley Hupf, Yunlong Yang, Ryan Gryder, Veronica Bunn & Jianchang Lin
Published online: 01 Apr 2024
  • 96 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Regional consistency assessment in multiregional clinical trials
Gang Li, Hui Quan & Yining Wang
Published online: 01 Apr 2024
  • 78 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Estimating treatment effect in randomized trial after control to treatment crossover using external controls
Xiner Zhou, Herbert Pang, Christiana Drake, Hans Ulrich Burger & Jiawen Zhu
Published online: 01 Apr 2024
  • 517 Views
  • 0 CrossRef citations
  • 0Altmetric
Open Access

Research Article

Article
Adaptively leverage multiple real-world data sources for treatment effect estimation based on similarity
Meihua Long, Jiali Song, Zhiwei Rong, Lan Mi, Yuqin Song & Yan Hou
Published online: 01 Apr 2024
  • 69 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
FDA experiences with a centralized statistical monitoring tool
Xiaofeng (Tina) Wang, Paul Schuette & Matilde Kam
Published online: 29 Mar 2024
  • 105 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Flexible seamless 2-in-1 design with sample size adaptation
Runjia Li, Liwen Wu, Rachael Liu & Jianchang Lin
Published online: 29 Mar 2024
  • 134 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Assessing the use of GEE methods for analyzing binary outcomes in family studies: the Strong Heart Family Study
Xi Chen, Ying Zhang, Amanda M. Fretts, Tauqeer Ali, Jason G. Umans, Richard B. Devereux, Elisa T. Lee, Shelley A. Cole & Yan Daniel Zhao
Published online: 29 Mar 2024
  • 54 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Transporting survival of an HIV clinical trial to the external target populations
Dasom Lee, Chenyin Gao, Sujit Ghosh & Shu Yang
Published online: 23 Mar 2024
  • 65 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
The use of real-world data for clinical investigation of effectiveness in drug development
Peijin Wang & Shein-Chung Chow
Published online: 22 Mar 2024
  • 110 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Assessing clinical response in early oncology development with a predictive biomarker
Shibing Deng, Feng Liu & Jadwiga Bienkowska
Published online: 22 Mar 2024
  • 32 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Association of the medication protocols and longitudinal change of COVID-19 symptoms: a hospital-based mixed-statistical methods study
Zahra Rezaei Ghahroodi, Samaneh Eftekhari Mahabadi, Alireza Esberizi, Ramin Sami & Marjan Mansourian
Published online: 21 Mar 2024
  • 45 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Incorporating external real-world data (RWD) in confirmatory adaptive design
Junjing Lin & Jianchang Lin
Published online: 21 Mar 2024
  • 160 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Analysis of innovative two-stage seamless adaptive design with different endpoints and population shift
Weijia Mai & Shein-Chung Chow
Published online: 21 Mar 2024
  • 61 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Bayesian spatial cluster signal learning with application to adverse event (AE)
Hou-Cheng Yang & Guanyu Hu
Published online: 21 Mar 2024
  • 49 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
A Bayesian approach based on discounting factor for consistency assessment in multi-regional clinical trial
Liang Tong, Chen Li, Jielai Xia & Ling Wang
Published online: 20 Mar 2024
  • 64 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
On the use of RWD in support of regulatory submission in drug development
Shein-Chung Chow & Peijin Wang
Published online: 19 Mar 2024
  • 162 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Establishment of RWS guidance reflecting contributions of China to regulatory science
Jun Wang, Jie Chen, Jun Zhao, Ying Wu, Xiaona Xin & Pingyan Chen
Published online: 17 Mar 2024
  • 129 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
DOD-Combo: Bayesian dose finding design in combination trials with meta-analytic-predictive prior
Kai Chen, Yunqi Zhao, Meizi Liu, Jianchang Lin & Rachael Liu
Published online: 11 Mar 2024
  • 119 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Modelling alternately recurring events using subject specific hazard estimation approach
Moumita Chatterjee, Sugata Sen Roy & Bhaswati Ganguli
Published online: 03 Mar 2024
  • 38 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
A basket trial design based on constrained hierarchical Bayesian model for latent subgroups
Kentaro Takeda, Atsuki Hashimoto, Shufang Liu & Alan Rong
Published online: 18 Feb 2024
  • 157 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Considerations for master protocols using external controls
Jie Chen, Xiaoyun (Nicole) Li, Chengxing (Cindy) Lu, Sammy Yuan, Godwin Yung, Jingjing Ye, Hong Tian & Jianchang Lin
Published online: 16 Feb 2024
  • 197 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
[Special issue PRO] Considering endpoints for comparative tolerability of cancer treatments using patient report given the estimand framework
John Devin Peipert, Monique Breslin, Ethan Basch, Melanie Calvert, David Cella, Mary Lou Smith, Gita Thanarajasingam & Jessica Roydhouse
Published online: 15 Feb 2024
  • 209 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
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
Gerasimos Dumi, Dara O’Neill, Christina Daskalopoulou, Tom Keeley, Stephanie Rhoten, Dharmraj Sauriyal & Piper Fromy
Published online: 14 Feb 2024
  • 809 Views
  • 0 CrossRef citations
  • 0Altmetric
Open Access

Research Article

Article
Miettinen and Nurminen score statistics revisited
Antonio Martín Andrés, Francisco Gayá Moreno, María Álvarez Hernández & Inmaculada Herranz Tejedor
Published online: 09 Feb 2024
  • 101 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Combination MCP-Mod for two-drug combination dose-ranging studies
Yifan Zhou, Abigail Sloan, Sandeep Menon & Ling Wang
Published online: 09 Feb 2024
  • 109 Views
  • 0 CrossRef citations
  • 0Altmetric

Review Article

Review Article
Sample size estimation for recurrent event data using multifrailty and multilevel survival models
Derek Dinart, Carine Bellera & Virginie Rondeau
Published online: 09 Feb 2024
  • 131 Views
  • 0 CrossRef citations
  • 0Altmetric

Research Article

Article
Interval estimation of relative risks for combined unilateral and bilateral correlated data
Kejia Wang & Chang-Xing Ma
Published online: 09 Jan 2024
  • 64 Views
  • 0 CrossRef citations
  • 0Altmetric
Sample our Bioscience journals, sign in here to start your access, Latest two full volumes FREE to you for 14 days