Pub Date : 2024-03-20DOI: 10.1080/19466315.2024.2332675
Tuo Wang, Ying Li, Yongming Qu
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...
{"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":null,"pages":null},"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}
Pub Date : 2024-03-20DOI: 10.1080/19466315.2024.2333388
H. Barnett, Oliver Boix, Dimitri Kontos, Thomas Jaki
{"title":"Joint TITE-CRM: A Design for Dose Finding Studies for Therapies with Late-Onset Safety and Activity Outcomes","authors":"H. Barnett, Oliver Boix, Dimitri Kontos, Thomas Jaki","doi":"10.1080/19466315.2024.2333388","DOIUrl":"https://doi.org/10.1080/19466315.2024.2333388","url":null,"abstract":"","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140227818","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}
Pub Date : 2024-03-08DOI: 10.1080/19466315.2024.2327290
Peng Zhang, Weichung Joe Shih, Yong Lin, K.K. Gordon Lan, Tai Xie
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...
{"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":null,"pages":null},"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}
Pub Date : 2024-03-06DOI: 10.1080/19466315.2024.2327303
Zhiwei Zhang, Jixian Wang, Dong Xi
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...
{"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":null,"pages":null},"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}
Pub Date : 2024-03-05DOI: 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
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...
{"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":null,"pages":null},"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}
Pub Date : 2024-02-06DOI: 10.1080/19466315.2024.2308882
Mitchell Aaron Schepps, Weng Kee Wong, Matt Austin, Volodymyr Anisimov
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...
{"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":null,"pages":null},"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}
Pub Date : 2024-02-05DOI: 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
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...
{"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":null,"pages":null},"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}
Pub Date : 2024-02-01DOI: 10.1080/19466315.2024.2305574
Published in Statistics in Biopharmaceutical Research (Vol. 16, No. 1, 2024)
发表于《生物制药研究统计》（第 16 卷第 1 期，2024 年）
{"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":null,"pages":null},"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}
Pub Date : 2024-01-23DOI: 10.1080/19466315.2024.2308877
Li Yang, Guoqing Diao, William F. Rosenberger
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...
{"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":null,"pages":null},"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}
Pub Date : 2024-01-23DOI: 10.1080/19466315.2024.2308856
David Dejardin, Bo Huang, Ying Yuan, Ulrich Beyer, Jane Fridlyand, Jiawen Zhu
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...
{"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":null,"pages":null},"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}
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