Pub Date : 2024-06-26DOI: 10.1080/19466315.2024.2368802
Kai Chen, Li Wang, Ying Yuan
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 ...
{"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}
Pub Date : 2024-06-26DOI: 10.1080/19466315.2024.2369266
Marian Mitroiu, Steven Teerenstra, Katrien Oude Rengerink, Frank Pétavy, Kit CB Roes
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...
我们的目标是探索数据生成模型，以联合模拟随机临床试验的结果和并发症，从而对估算值进行调查。
{"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}
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 ...
{"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}
Pub Date : 2024-06-26DOI: 10.1080/19466315.2024.2370403
Mengyi Lu, Jingyi Zhang, Ying Yuan, Ruitao Lin
Drug combinations are increasingly utilized in cancer treatment to enhance drug effectiveness through synergistic therapeutic effects. However, determining the optimal biological dose combination (...
癌症治疗中越来越多地使用联合用药，通过协同治疗效果提高药物疗效。然而，确定最佳生物剂量组合（...
{"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}
Pub Date : 2024-06-21DOI: 10.1080/19466315.2024.2370405
Yu-Chieh Cheng, Hsiao-Hui Tsou, H.M.James Hung, Byron Fan, Brandon Fan
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...
{"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}
Pub Date : 2024-06-17DOI: 10.1080/19466315.2024.2368789
Se Yoon Lee
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...
{"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}
Pub Date : 2024-06-17DOI: 10.1080/19466315.2024.2368787
David K. Lim, Naim U. Rashid, Junier B. Oliva, Joseph G. Ibrahim
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...
{"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}
Pub Date : 2024-06-10DOI: 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
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...
{"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}
Pub Date : 2024-04-30DOI: 10.1080/19466315.2024.2342817
Nicky Best, Maxine Ajimi, Beat Neuenschwander, Gaëlle Saint-Hilary, Simon Wandel
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...
{"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}
Pub Date : 2024-03-26DOI: 10.1080/19466315.2024.2334354
Keaven M. Anderson, Yujie Zhao, Nan Xiao, Joy Ge, Harlan F. Weisman
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...
{"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}
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