跨制药非比例风险工作组对“非比例风险——对MaxCombo试验在癌症临床试验中的评价”的评论

IF 1.5 4区医学 Q3 MATHEMATICAL & COMPUTATIONAL BIOLOGY

Statistics in Biopharmaceutical Research Pub Date : 2023-04-03 DOI:10.1080/19466315.2022.2103180

Ray S. Lin, P. Mukhopadhyay, Satrajit Roychoudhury, K. Anderson, Tianle Hu, Bo Huang, L. F. León, J. Liao, Ji Lin, Rong Liu, Xiaodong Luo, Yabing Mai, R. Qin, K. Tatsuoka, Yang Wang, Jiabu Ye, Jian Zhu, Tai-Tsang Chen, R. Iacona

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引用次数: 1

摘要

aGenentech/Roche，南旧金山，加利福尼亚州;bOtsuka America Pharmaceuticals, Inc .， Rockville, MD, 20850;纽约cpizer公司;d默克公司，新泽西州凯尼尔沃斯;eSarepta Therapeutics, Cambridge, MA;辉瑞公司，格罗顿，康涅狄格州;gIncyte Corporation, Wilmington, DE;赛诺菲美国，剑桥，马萨诸塞州;bristol myers Squibb，伯克利高地，新泽西;赛诺菲美国，布里奇沃特，新泽西;勃林格殷格翰，上海，中国;janssen Research & Development, LLC, NJ;santen制药公司，加利福尼亚州埃默里维尔;nZ&W咨询公司，切斯特斯普林斯，宾夕法尼亚州;oServier Pharmaceuticals, Boston, MA;pGSK，学院维尔，宾夕法尼亚州;qAstra Zeneca，华盛顿特区;rcross - pharma NPH工作组包括上述手稿的所有作者以及以下对这项工作做出巨大贡献的成员:Prabhu Bhagavatheeswaran, Julie丛婧，Margarida Geraldes, Dominik Heinzmann，黄一凡，李正容，刘洪路，钱简，王学静，徐丽安，赵鲁平

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Comment on “Non-Proportional Hazards – an Evaluation of the MaxCombo Test in Cancer Clinical Trials” by the Cross-Pharma Non-Proportional Hazards Working Group

aGenentech/Roche, South San Francisco, CA; bOtsuka America Pharmaceuticals, Inc, Rockville, MD, 20850; cPfizer Inc, New York, NY; dMerck & Co., Inc, Kenilworth, NJ; eSarepta Therapeutics, Cambridge, MA; fPfizer Inc, Groton, CT; gIncyte Corporation, Wilmington, DE; hSanofi US, Cambridge, MA; iBristolMyers Squibb, Berkeley Heights, NJ; jSanofi US, Bridgewater, NJ; kBoehringer Ingelheim, Shanghai, China; lJanssen Research & Development, LLC, Raritan, NJ; mSanten Pharmaceuticals, Emeryville, CA; nZ&W Consulting, Chester Springs, PA; oServier Pharmaceuticals, Boston, MA; pGSK, Collegeville, PA; qAstra Zeneca, Washington, DC; rThe Cross-Pharma NPH working group includes all the authors of this manuscript as listed above and the following members who have contributed tremendously to this work: Prabhu Bhagavatheeswaran, Julie Cong, Margarida Geraldes, Dominik Heinzmann, Yifan Huang, Zhengrong Li, Honglu Liu, Jane Qian, Xuejing Wang, Li-an Xu, Luping Zhao

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来源期刊

Statistics in Biopharmaceutical Research MATHEMATICAL & COMPUTATIONAL BIOLOGY-STATISTICS & PROBABILITY

CiteScore

3.90

自引率

16.70%

发文量

期刊介绍： Statistics in Biopharmaceutical Research ( SBR), publishes articles that focus on the needs of researchers and applied statisticians in biopharmaceutical industries; academic biostatisticians from schools of medicine, veterinary medicine, public health, and pharmacy; statisticians and quantitative analysts working in regulatory agencies (e.g., U.S. Food and Drug Administration and its counterpart in other countries); statisticians with an interest in adopting methodology presented in this journal to their own fields; and nonstatisticians with an interest in applying statistical methods to biopharmaceutical problems. Statistics in Biopharmaceutical Research accepts papers that discuss appropriate statistical methodology and information regarding the use of statistics in all phases of research, development, and practice in the pharmaceutical, biopharmaceutical, device, and diagnostics industries. Articles should focus on the development of novel statistical methods, novel applications of current methods, or the innovative application of statistical principles that can be used by statistical practitioners in these disciplines. Areas of application may include statistical methods for drug discovery, including papers that address issues of multiplicity, sequential trials, adaptive designs, etc.; preclinical and clinical studies; genomics and proteomics; bioassay; biomarkers and surrogate markers; models and analyses of drug history, including pharmacoeconomics, product life cycle, detection of adverse events in clinical studies, and postmarketing risk assessment; regulatory guidelines, including issues of standardization of terminology (e.g., CDISC), tolerance and specification limits related to pharmaceutical practice, and novel methods of drug approval; and detection of adverse events in clinical and toxicological studies. Tutorial articles also are welcome. Articles should include demonstrable evidence of the usefulness of this methodology (presumably by means of an application). The Editorial Board of SBR intends to ensure that the journal continually provides important, useful, and timely information. To accomplish this, the board strives to attract outstanding articles by seeing that each submission receives a careful, thorough, and prompt review. Authors can choose to publish gold open access in this journal.