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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
Weighted Hazard Ratio Estimation for Delayed and Diminishing Treatment Effect 延迟和递减治疗效果的加权危险比估计
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-01-05 DOI: 10.1080/19466315.2023.2289514
Bharati Kumar, Jonathan W. Bartlett
{"title":"Weighted Hazard Ratio Estimation for Delayed and Diminishing Treatment Effect","authors":"Bharati Kumar, Jonathan W. Bartlett","doi":"10.1080/19466315.2023.2289514","DOIUrl":"https://doi.org/10.1080/19466315.2023.2289514","url":null,"abstract":"Nonproportional hazards (NPH) have been observed in confirmatory clinical trials with time to event outcomes. Under NPH, the hazard ratio does not stay constant over time and the log rank test is n...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"38 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139103532","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
Effects of Allocation Method and Time Trends on Identification of the Best Arm in Multi-arm Trials 分配方法和时间趋势对确定多臂试验最佳臂的影响
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-01-02 DOI: 10.1080/19466315.2023.2298961
Lindsay R Berry, Elizabeth Lorenzi, Nicholas S Berry, Amy M Crawford, Peter Jacko, Kert Viele
{"title":"Effects of Allocation Method and Time Trends on Identification of the Best Arm in Multi-arm Trials","authors":"Lindsay R Berry, Elizabeth Lorenzi, Nicholas S Berry, Amy M Crawford, Peter Jacko, Kert Viele","doi":"10.1080/19466315.2023.2298961","DOIUrl":"https://doi.org/10.1080/19466315.2023.2298961","url":null,"abstract":"Many trial designs, such as dose-finding trials, shared-control designs, or adaptive platform trials, investigate multiple therapies simultaneously. Often these trials seek to identify the best arm...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"34 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139083546","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
Estimands in oncology early clinical development: Assessing the impact of intercurrent events on the dose-toxicity relationship 肿瘤学早期临床开发中的估计剂量：评估并发症对剂量毒性关系的影响
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2023-12-18 DOI: 10.1080/19466315.2023.2296648
Francois Mercier, Victoria Homer, Junxian Geng, Hontao Zhang, Stefan Englert, Natalia Kan-Dobrosky, Anja Victor
{"title":"Estimands in oncology early clinical development: Assessing the impact of intercurrent events on the dose-toxicity relationship","authors":"Francois Mercier, Victoria Homer, Junxian Geng, Hontao Zhang, Stefan Englert, Natalia Kan-Dobrosky, Anja Victor","doi":"10.1080/19466315.2023.2296648","DOIUrl":"https://doi.org/10.1080/19466315.2023.2296648","url":null,"abstract":"The R1 addendum to ICH E9 (E9-R1) provides guidance on the definition of estimands in clinical drug development. While the E9-R1 has seen uptake in randomized late-stage clinical trials, its implem...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"307 3 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2023-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138821316","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
Conditional and Unconditional treatment effects in randomized clinical trials: Estimands, Estimation, and Interpretation 随机临床试验中的有条件和无条件治疗效果：估计因子、估计和解释
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2023-12-12 DOI: 10.1080/19466315.2023.2292774
Jiawei Wei, Jiajun Xu, Björn Bornkamp, Ray Lin, Hong Tian, Dong Xi, Xin Zhang, Ziqiang Zhao, Satrajit Roychoudhury
{"title":"Conditional and Unconditional treatment effects in randomized clinical trials: Estimands, Estimation, and Interpretation","authors":"Jiawei Wei, Jiajun Xu, Björn Bornkamp, Ray Lin, Hong Tian, Dong Xi, Xin Zhang, Ziqiang Zhao, Satrajit Roychoudhury","doi":"10.1080/19466315.2023.2292774","DOIUrl":"https://doi.org/10.1080/19466315.2023.2292774","url":null,"abstract":"ICH E9(R1) specifies the importance of precisely defining the treatment effect for clinical trials – to inform patient choices and facilitate evidence-based decision-making. FDA's guidance on covar...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"33 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2023-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138686311","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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