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Statistics in Biopharmaceutical Research最新文献

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MT-Keyboard: A Bayesian Model-assisted Interval Design to Account for Toxicity Grades and Types for Phase I Trials MT-Keyboard：贝叶斯模型辅助区间设计，用于考虑 I 期试验的毒性等级和类型
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-26 DOI: 10.1080/19466315.2024.2368802
Kai Chen, Li Wang, Ying Yuan
{"title":"MT-Keyboard: A Bayesian Model-assisted Interval Design to Account for Toxicity Grades and Types for Phase I Trials","authors":"Kai Chen, Li Wang, Ying Yuan","doi":"10.1080/19466315.2024.2368802","DOIUrl":"https://doi.org/10.1080/19466315.2024.2368802","url":null,"abstract":"Conventionally, dose finding trials are based on dose-limiting toxicity (DLT) that only captures the most severe toxicities, e.g., treatment related grade 3 or higher toxicity according to the NCI ...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"15 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141516509","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
Possible data-generating models of longitudinal continuous outcomes and intercurrent events to investigate estimands 纵向连续结果和并发事件的可能数据生成模型，以调查估计值
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-26 DOI: 10.1080/19466315.2024.2369266
Marian Mitroiu, Steven Teerenstra, Katrien Oude Rengerink, Frank Pétavy, Kit CB Roes
{"title":"Possible data-generating models of longitudinal continuous outcomes and intercurrent events to investigate estimands","authors":"Marian Mitroiu, Steven Teerenstra, Katrien Oude Rengerink, Frank Pétavy, Kit CB Roes","doi":"10.1080/19466315.2024.2369266","DOIUrl":"https://doi.org/10.1080/19466315.2024.2369266","url":null,"abstract":"We aimed to explore data-generating models to jointly simulate outcomes and intercurrent events for randomised clinical trials to enable the investigation of estimands.We developed four possible da...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"96 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141507320","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 statistical method for protocol modifications with heterogeneous population variances 具有异质群体方差的协议修改统计方法
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-26 DOI: 10.1080/19466315.2024.2369267
Chieh Chiang, Yuh-Jenn Wu, Li-Hsueh Cheng, Ching-Ti Liu, Chin-Fu Hsiao
{"title":"A statistical method for protocol modifications with heterogeneous population variances","authors":"Chieh Chiang, Yuh-Jenn Wu, Li-Hsueh Cheng, Ching-Ti Liu, Chin-Fu Hsiao","doi":"10.1080/19466315.2024.2369267","DOIUrl":"https://doi.org/10.1080/19466315.2024.2369267","url":null,"abstract":"During the course of a clinical trial, the procedure may need to be modified based on medical or practical results. For example, in trials with low recruitment rates, the data monitoring committee ...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"145 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141613835","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
Comb-BOIN12: A Utility-Based Bayesian Optimal Interval Design for Dose Optimization in Cancer Drug-Combination Trials Comb-BOIN12：基于效用的贝叶斯最佳区间设计，用于癌症联合用药试验中的剂量优化
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-26 DOI: 10.1080/19466315.2024.2370403
Mengyi Lu, Jingyi Zhang, Ying Yuan, Ruitao Lin
{"title":"Comb-BOIN12: A Utility-Based Bayesian Optimal Interval Design for Dose Optimization in Cancer Drug-Combination Trials","authors":"Mengyi Lu, Jingyi Zhang, Ying Yuan, Ruitao Lin","doi":"10.1080/19466315.2024.2370403","DOIUrl":"https://doi.org/10.1080/19466315.2024.2370403","url":null,"abstract":"Drug combinations are increasingly utilized in cancer treatment to enhance drug effectiveness through synergistic therapeutic effects. However, determining the optimal biological dose combination (...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"74 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141615027","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
Establishing and using threshold of surrogate endpoint in relation to clinical endpoint# 建立和使用与临床终点相关的替代终点阈值#
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-21 DOI: 10.1080/19466315.2024.2370405
Yu-Chieh Cheng, Hsiao-Hui Tsou, H.M.James Hung, Byron Fan, Brandon Fan
{"title":"Establishing and using threshold of surrogate endpoint in relation to clinical endpoint#","authors":"Yu-Chieh Cheng, Hsiao-Hui Tsou, H.M.James Hung, Byron Fan, Brandon Fan","doi":"10.1080/19466315.2024.2370405","DOIUrl":"https://doi.org/10.1080/19466315.2024.2370405","url":null,"abstract":"Clinical trials are an essential aspect of the drug development process. Clinical endpoints and surrogate endpoints are two terms used in clinical trials to measure the effectiveness of a treatment...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"247 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141613836","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
Eliciting the discount parameter in a power prior method on the basis of the type I error consideration 基于 I 型误差的考虑，在幂先验法中得出折扣参数
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-17 DOI: 10.1080/19466315.2024.2368789
Se Yoon Lee
{"title":"Eliciting the discount parameter in a power prior method on the basis of the type I error consideration","authors":"Se Yoon Lee","doi":"10.1080/19466315.2024.2368789","DOIUrl":"https://doi.org/10.1080/19466315.2024.2368789","url":null,"abstract":"In Bayesian clinical trial design, the power prior methodology offers a flexible framework for incorporating historical data into the analysis. One critical aspect of this approach is determining t...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"90 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141613969","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
Unsupervised Imputation of Non-ignorably Missing Data Using Importance-Weighted Autoencoders 使用重要性加权自动编码器对非明显缺失数据进行无监督处理
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-17 DOI: 10.1080/19466315.2024.2368787
David K. Lim, Naim U. Rashid, Junier B. Oliva, Joseph G. Ibrahim
{"title":"Unsupervised Imputation of Non-ignorably Missing Data Using Importance-Weighted Autoencoders","authors":"David K. Lim, Naim U. Rashid, Junier B. Oliva, Joseph G. Ibrahim","doi":"10.1080/19466315.2024.2368787","DOIUrl":"https://doi.org/10.1080/19466315.2024.2368787","url":null,"abstract":"Deep Learning (DL) methods have dramatically increased in popularity in recent years. While its initial success was demonstrated in the classification and manipulation of image data, there has been...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"63 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141530915","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 overall survival in pivotal trials in indolent cancers 监测偶发性癌症关键试验的总生存率
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-06-10 DOI: 10.1080/19466315.2024.2365648
Thomas R Fleming, Lisa V Hampson, Bharani-Dharan Bharani, Frank Bretz, Arunava Chakravartty, Thibaud Coroller, Evanthia Koukouli, Janet Wittes, Nigel Yateman, Emmanuel Zuber
{"title":"Monitoring overall survival in pivotal trials in indolent cancers","authors":"Thomas R Fleming, Lisa V Hampson, Bharani-Dharan Bharani, Frank Bretz, Arunava Chakravartty, Thibaud Coroller, Evanthia Koukouli, Janet Wittes, Nigel Yateman, Emmanuel Zuber","doi":"10.1080/19466315.2024.2365648","DOIUrl":"https://doi.org/10.1080/19466315.2024.2365648","url":null,"abstract":"Indolent cancers are characterized by long overall survival (OS) times. Therefore, powering a clinical trial to provide definitive assessment of the effects of an experimental intervention on OS in...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"26 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141507322","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
Beyond the classical type I error: Bayesian metrics for Bayesian designs using informative priors 超越经典的 I 型误差：使用信息先验的贝叶斯设计的贝叶斯度量方法
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-04-30 DOI: 10.1080/19466315.2024.2342817
Nicky Best, Maxine Ajimi, Beat Neuenschwander, Gaëlle Saint-Hilary, Simon Wandel
{"title":"Beyond the classical type I error: Bayesian metrics for Bayesian designs using informative priors","authors":"Nicky Best, Maxine Ajimi, Beat Neuenschwander, Gaëlle Saint-Hilary, Simon Wandel","doi":"10.1080/19466315.2024.2342817","DOIUrl":"https://doi.org/10.1080/19466315.2024.2342817","url":null,"abstract":"There is growing interest in Bayesian clinical trial designs with informative prior distributions, e.g. for extrapolation of adult data to pediatrics, or use of external controls. While the classic...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"15 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140886861","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
Some group sequential trials from industry over the last 30 years 过去 30 年工业界的一些分组顺序试验
IF 1.8 4区 医学
Statistics in Biopharmaceutical Research Pub Date : 2024-03-26 DOI: 10.1080/19466315.2024.2334354
Keaven M. Anderson, Yujie Zhao, Nan Xiao, Joy Ge, Harlan F. Weisman
{"title":"Some group sequential trials from industry over the last 30 years","authors":"Keaven M. Anderson, Yujie Zhao, Nan Xiao, Joy Ge, Harlan F. Weisman","doi":"10.1080/19466315.2024.2334354","DOIUrl":"https://doi.org/10.1080/19466315.2024.2334354","url":null,"abstract":"We consider several industry group sequential trials and associated issues over the last 30 years. Generally, group sequential design has provided a great deal of flexibility to overcome many chall...","PeriodicalId":51280,"journal":{"name":"Statistics in Biopharmaceutical Research","volume":"73 1","pages":""},"PeriodicalIF":1.8,"publicationDate":"2024-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140311791","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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