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Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective 肿瘤剂量优化的设计策略与考虑因素：行业视角
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-03-25 DOI: 10.1080/19466315.2024.2332650
Rong Liu, Ying Yuan, Suman Sen, Olga Marchenko, Qi Jiang, Hong Tian, Xiaoyun Li, Ruitao Lin, Cindy Lu, Heng Zhou
{"title":"Design Strategy and Consideration for Oncology Dose-Optimization: An Industry Perspective","authors":"Rong Liu, Ying Yuan, Suman Sen, Olga Marchenko, Qi Jiang, Hong Tian, Xiaoyun Li, Ruitao Lin, Cindy Lu, Heng Zhou","doi":"10.1080/19466315.2024.2332650","DOIUrl":"https://doi.org/10.1080/19466315.2024.2332650","url":null,"abstract":"The conventional more-is-better dose selection paradigm is often inappropriate for novel molecularly targeted agents. In response, the US Food and Drug Administration (FDA) initiated Project Optimu...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"143 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140311921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Restricted time win ratio: from estimands to estimation 限制时间胜率：从估算到估算
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-03-20 DOI: 10.1080/19466315.2024.2332675
Tuo Wang, Ying Li, Yongming Qu
{"title":"Restricted time win ratio: from estimands to estimation","authors":"Tuo Wang, Ying Li, Yongming Qu","doi":"10.1080/19466315.2024.2332675","DOIUrl":"https://doi.org/10.1080/19466315.2024.2332675","url":null,"abstract":"The win ratio is a novel approach to analyzing prioritized composite endpoints in clinical trials. The win ratio has grown increasingly popular and has been applied in many ongoing cardiovascular c...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"68 3 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140205584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Monitoring Ongoing Clinical Trials under Fractional Brownian Motion with Drift 在带漂移的分数布朗运动条件下监测正在进行的临床试验
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-03-08 DOI: 10.1080/19466315.2024.2327290
Peng Zhang, Weichung Joe Shih, Yong Lin, K.K. Gordon Lan, Tai Xie
{"title":"Monitoring Ongoing Clinical Trials under Fractional Brownian Motion with Drift","authors":"Peng Zhang, Weichung Joe Shih, Yong Lin, K.K. Gordon Lan, Tai Xie","doi":"10.1080/19466315.2024.2327290","DOIUrl":"https://doi.org/10.1080/19466315.2024.2327290","url":null,"abstract":"The standard Brownian motion (Bm) with a linear drift is a convenient statistical structure for monitoring ongoing clinical trials in practice for more than four decades (Lan and DeMets, 1983). Und...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"19 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140070410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An Instrumental Variable Approach to Learning the Causal Exposure-Response Relationship in a Randomized Dose Comparison Trial 在随机剂量比较试验中学习暴露-反应因果关系的工具变量方法
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-03-06 DOI: 10.1080/19466315.2024.2327303
Zhiwei Zhang, Jixian Wang, Dong Xi
{"title":"An Instrumental Variable Approach to Learning the Causal Exposure-Response Relationship in a Randomized Dose Comparison Trial","authors":"Zhiwei Zhang, Jixian Wang, Dong Xi","doi":"10.1080/19466315.2024.2327303","DOIUrl":"https://doi.org/10.1080/19466315.2024.2327303","url":null,"abstract":"We consider the problem of estimating the causal effect of drug exposure on clinical response in a randomized dose comparison trial where each group receives a different dose. Because exposure is n...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"5 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140044210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Implementation of statistical innovation in a pharmaceutical company 制药公司实施统计创新
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-03-05 DOI: 10.1080/19466315.2024.2327291
Kaspar Rufibach, Marcel Wolbers, Jenny Devenport, Godwin Yung, Chris Harbron, Alun Bedding, Zhiyue Huang, Ray Lin, Herbert Pang, Daniel SabanésBové, Jianmei Wang
{"title":"Implementation of statistical innovation in a pharmaceutical company","authors":"Kaspar Rufibach, Marcel Wolbers, Jenny Devenport, Godwin Yung, Chris Harbron, Alun Bedding, Zhiyue Huang, Ray Lin, Herbert Pang, Daniel SabanésBové, Jianmei Wang","doi":"10.1080/19466315.2024.2327291","DOIUrl":"https://doi.org/10.1080/19466315.2024.2327291","url":null,"abstract":"Innovation, defined as the successful implementation at scale of a new invention, is key for continued success of the drug development enterprise. In this paper we focus on statistical innovation i...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"35 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140034187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optimizing Patient Recruitment in Global Clinical Trials using Nature-Inspired Metaheuristics 利用受自然启发的元启发算法优化全球临床试验中的患者招募工作
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-02-06 DOI: 10.1080/19466315.2024.2308882
Mitchell Aaron Schepps, Weng Kee Wong, Matt Austin, Volodymyr Anisimov
{"title":"Optimizing Patient Recruitment in Global Clinical Trials using Nature-Inspired Metaheuristics","authors":"Mitchell Aaron Schepps, Weng Kee Wong, Matt Austin, Volodymyr Anisimov","doi":"10.1080/19466315.2024.2308882","DOIUrl":"https://doi.org/10.1080/19466315.2024.2308882","url":null,"abstract":"A common problem seen in the ineffective execution of global multicenter trials is the frequent inability to recruit a sufficient number of patients. A myriad of barriers to recruiting enough patie...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"77 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139763262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bayesian and Frequentist Approaches to Rescuing Disrupted Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions 贝叶斯和频数法挽救中断的试验：NISS 英格拉姆-奥尔金计划外临床试验中断系列论坛报告
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-02-05 DOI: 10.1080/19466315.2024.2313986
Cornelia Ursula Kunz, Sergey Tarima, Gary L. Rosner, Richard Emsley, Madeline Bauer, Christopher Jennison, James L. Rosenberger, Nigel Stallard, Sarah Zohar, Nancy Flournoy
{"title":"Bayesian and Frequentist Approaches to Rescuing Disrupted Trials: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions","authors":"Cornelia Ursula Kunz, Sergey Tarima, Gary L. Rosner, Richard Emsley, Madeline Bauer, Christopher Jennison, James L. Rosenberger, Nigel Stallard, Sarah Zohar, Nancy Flournoy","doi":"10.1080/19466315.2024.2313986","DOIUrl":"https://doi.org/10.1080/19466315.2024.2313986","url":null,"abstract":"The COVID-19 pandemic impacted clinical trials in ways never expected. However, similar challenges should now be expected going forward. These challenges made us aware of statistical problems arisi...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"87 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139763362","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Statistics in Biopharmaceutical Research 2023 Associate Editors 生物制药研究统计 2023》副主编
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-02-01 DOI: 10.1080/19466315.2024.2305574
{"title":"Statistics in Biopharmaceutical Research 2023 Associate Editors","authors":"","doi":"10.1080/19466315.2024.2305574","DOIUrl":"https://doi.org/10.1080/19466315.2024.2305574","url":null,"abstract":"Published in Statistics in Biopharmaceutical Research (Vol. 16, No. 1, 2024)","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"21 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139662384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design 两阶段共变因素调整反应适应性强化设计
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-01-23 DOI: 10.1080/19466315.2024.2308877
Li Yang, Guoqing Diao, William F. Rosenberger
{"title":"A Two-Stage Covariate-Adjusted Response-Adaptive Enrichment Design","authors":"Li Yang, Guoqing Diao, William F. Rosenberger","doi":"10.1080/19466315.2024.2308877","DOIUrl":"https://doi.org/10.1080/19466315.2024.2308877","url":null,"abstract":"In the precision medicine paradigm, it is of interest to identify subgroups that benefit most from the treatment. However, the subgroup often cannot be identified until after a large-scale clinical...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"41 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139578736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Dose Optimization for Novel Oncology Agents: Design Options and Strategies 新型肿瘤药物的剂量优化：设计方案和策略
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-01-23 DOI: 10.1080/19466315.2024.2308856
David Dejardin, Bo Huang, Ying Yuan, Ulrich Beyer, Jane Fridlyand, Jiawen Zhu
{"title":"Dose Optimization for Novel Oncology Agents: Design Options and Strategies","authors":"David Dejardin, Bo Huang, Ying Yuan, Ulrich Beyer, Jane Fridlyand, Jiawen Zhu","doi":"10.1080/19466315.2024.2308856","DOIUrl":"https://doi.org/10.1080/19466315.2024.2308856","url":null,"abstract":"Over the past decade, drug development in oncology has shifted from cytotoxic agents to drugs with new mechanisms of action, such as cancer immunotherapies, targeted therapeutics, T-cell engagers a...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"7 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139590480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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