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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
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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
Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing 通过基于倾向分数的外部数据借用预测 III 期试验的成功概率
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2023-12-12 DOI: 10.1080/19466315.2023.2292815
Jennifer L. Proper, Veronica Bunn, Bradley Hupf, Jianchang Lin
{"title":"Predicting Probability of Success for Phase III Trials via Propensity-Score-Based External Data Borrowing","authors":"Jennifer L. Proper, Veronica Bunn, Bradley Hupf, Jianchang Lin","doi":"10.1080/19466315.2023.2292815","DOIUrl":"https://doi.org/10.1080/19466315.2023.2292815","url":null,"abstract":"Given the rising costs and time length of confirmatory phase III trials, drug developers have become increasingly reliant on quantitative methods to support critical decisions such as whether drug ...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"18 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2023-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631875","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
Treatment Comparisons in Adaptive Platform Trials Adjusting for Temporal Drift 调整时间漂移的自适应平台试验中的治疗比较
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2023-12-11 DOI: 10.1080/19466315.2023.2292238
Beibei Guo, Li Wang, Ying Yuan
{"title":"Treatment Comparisons in Adaptive Platform Trials Adjusting for Temporal Drift","authors":"Beibei Guo, Li Wang, Ying Yuan","doi":"10.1080/19466315.2023.2292238","DOIUrl":"https://doi.org/10.1080/19466315.2023.2292238","url":null,"abstract":"An adaptive platform trial (APT) is a multi-arm trial in the context of a single disease where treatment arms are allowed to enter or leave the trial based on some decision rule. If a treatment ent...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"21 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2023-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138567738","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
DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials DODII：随机 II 期试验的贝叶斯剂量优化设计
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2023-12-07 DOI: 10.1080/19466315.2023.2292816
Ziji Yu, Yanzhao Wang, Jianchang Lin
{"title":"DODII: Bayesian Dose Optimization Design for Randomized Phase II Trials","authors":"Ziji Yu, Yanzhao Wang, Jianchang Lin","doi":"10.1080/19466315.2023.2292816","DOIUrl":"https://doi.org/10.1080/19466315.2023.2292816","url":null,"abstract":"The traditional MTD-based dose selection paradigm commonly used for cytotoxic chemotherapies might not be optimal for targeted therapies because a higher dose does not necessarily result in improve...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"10 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2023-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138575947","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
Joint Analysis of Longitudinal Ordinal Categorical Item Response Data and Survival Times with Cure Fraction 纵向有序分类项目反应数据与治愈分数生存时间的联合分析
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2023-11-30 DOI: 10.1080/19466315.2023.2290642
Ming Chi, Xiaogang Wang, Hui Song, Yingwei Peng, Dongsheng Tu
{"title":"Joint Analysis of Longitudinal Ordinal Categorical Item Response Data and Survival Times with Cure Fraction","authors":"Ming Chi, Xiaogang Wang, Hui Song, Yingwei Peng, Dongsheng Tu","doi":"10.1080/19466315.2023.2290642","DOIUrl":"https://doi.org/10.1080/19466315.2023.2290642","url":null,"abstract":"For longitudinal ordinal categorical item response data which may not be observable after a subject develops a terminal event, some statistical models have been proposed for the joint analysis of t...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"243 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2023-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138516362","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
Adjusting for time-varying treatment switches in randomized clinical trials: the danger of extrapolation and how to address it 在随机临床试验中调整时变治疗开关:外推的危险及如何解决
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2023-11-29 DOI: 10.1080/19466315.2023.2289523
Hege Michiels, An Vandebosch, Stijn Vansteelandt
{"title":"Adjusting for time-varying treatment switches in randomized clinical trials: the danger of extrapolation and how to address it","authors":"Hege Michiels, An Vandebosch, Stijn Vansteelandt","doi":"10.1080/19466315.2023.2289523","DOIUrl":"https://doi.org/10.1080/19466315.2023.2289523","url":null,"abstract":"When choosing estimands and estimators in randomized clinical trials, caution is warranted, as intercurrent events, such as, due to patients who switch treatment after disease progression, are ofte...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"17 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2023-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138516352","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
Isotonic Phase I cancer clinical trial design utilizing patient-reported outcomes 等渗I期癌症临床试验设计利用患者报告的结果
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2023-11-28 DOI: 10.1080/19466315.2023.2288013
Nolan A. Wages, Ruitao Lin
{"title":"Isotonic Phase I cancer clinical trial design utilizing patient-reported outcomes","authors":"Nolan A. Wages, Ruitao Lin","doi":"10.1080/19466315.2023.2288013","DOIUrl":"https://doi.org/10.1080/19466315.2023.2288013","url":null,"abstract":"This article considers the concept of designing Phase I clinical trials using both clinician- and patient-reported outcomes to adaptively allocate study participants to tolerable doses and determin...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"13 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2023-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138516325","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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