有咨询委员会会议准备和执行的经验

IF 1.5 4区医学 Q3 MATHEMATICAL & COMPUTATIONAL BIOLOGY Statistics in Biopharmaceutical Research Pub Date : 2023-07-03 DOI:10.1080/19466315.2023.2210079

C. Gause, Jing Zhao

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引用次数: 0

摘要

FDA使用咨询委员会和小组在科学、技术和政策问题上获得独立的专家意见。如果fda对提交审查的临床数据有重大疑问或担忧，可以召开咨询委员会会议(ACMs)。来自FDA和行业的统计人员可以发挥关键作用，为ACM中审查的数据提供洞察力。这需要广泛的准备和规划，这超出了提交包中提供的数据。在本文中，我们回顾了行业统计学家在acm的规划、准备和响应方面的贡献。

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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Experience with Advisory Committee Meeting Preparation and Execution

Abstract The FDA uses advisory committees and panels to obtain independent expert advice on scientific, technical, and policy matters. Advisory Committee Meetings (ACMs) may be convened if the agency has significant questions or concerns about clinical data submitted for review. Statisticians from both FDA and industry can play a key role in providing insight into the data under review in an ACM. This requires extensive preparation and planning which extends beyond the data provided in the submission package. In this article, we review the contributions of industry Statisticians in the planning, preparation and responses for ACMs.

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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.