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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
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
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