Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments
暫譯: 醫療產品開發中的利益-風險評估方法：連結定性與定量評估

Jiang, Qi, He, Weili

Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments
  • 出版商: CRC
  • 出版日期: 2020-12-18
  • 售價: $2,400
  • 貴賓價: 9.5 折 $2,280
  • 語言: 英文
  • 頁數: 296
  • 裝訂: Quality Paper - also called trade paper
  • ISBN: 0367737086
  • ISBN-13: 9780367737085

    • 海外代購書籍(需單獨結帳)

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商品描述

Guides You on the Development and Implementation of B-R Evaluations



Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit-risk (B-R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B-R assessment in clinical development and regulatory submission.





The first section of the book discusses the role of B-R assessments in medicine development and regulation, the need for both a common B-R framework and patient input into B-R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA's Center for Devices and Radiological Health. The third section examines key elements of B-R evaluations in a product's life cycle, such as uncertainty evaluation and quantification, quantifying patient B-R trade-off preferences, ways to identify subgroups with the best B-R profiles, and data sources used to assist B-R assessment. The fourth section equips practitioners with tools to conduct B-R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies.





With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B-R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B-R evaluations.

商品描述(中文翻譯)

指導您進行利益-風險評估的開發與實施

醫療產品開發中的利益-風險評估方法：橋接定性與定量評估提供一般指導和案例研究，以幫助從業者選擇特定的利益-風險（B-R）框架和定量方法。來自業界、監管機構和學術界的領先專家提供實用範例、經驗教訓和最佳實踐，說明如何在臨床開發和監管提交中進行結構化的B-R評估。

本書的第一部分討論了B-R評估在醫藥開發和監管中的角色，對於共同的B-R框架和患者對B-R決策的輸入的需求，以及未來的方向。第二部分專注於立法和監管政策倡議，以及美國FDA設備與放射健康中心所做的決策。第三部分檢視產品生命週期中B-R評估的關鍵要素，例如不確定性評估與量化、量化患者的B-R權衡偏好、識別具有最佳B-R特徵的子群體的方法，以及用於協助B-R評估的數據來源。第四部分為從業者提供進行B-R評估的工具，包括評估方法論、定量聯合建模和聯合評估框架，以及幾個可視化工具。最後一部分呈現了豐富的案例研究集。

隨著頂尖專家分享他們的深入知識、引人深思的考量和實用建議，本書全面涵蓋了B-R評估方法、工具和案例研究。它為從業者提供了開發和進行自身B-R評估所需的工具包。

作者簡介

Dr. Qi Jiang is an executive director of Global Biostatistical Science at Amgen. In this role, she is the biostatistical therapeutic area head for oncology and hematology and the lead of the Center of Excellence for Safety and Benefit-Risk. In addition, Dr. Jiang provides oversight to Amgen's biostatistical efforts in the Asia-Pacific region. Before joining Amgen, she worked at the Harvard School of Public Health, Merck, and Novartis. Dr. Jiang is the co-editor of the Chapman & Hall/CRC book Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting and the author of more than 60 peer-reviewed publications on method development, study design, and data analysis and reporting. She is a fellow of the American Statistical Association, a co-lead of the American Statistical Association Biopharmaceutical Section Safety Working Group, a co-lead of the Quantitative Sciences in the Pharmaceutical Industry (QSPI) Benefit-Risk Working Group, and an associate editor for Statistics in Biopharmaceutical Research.



Dr. Weili He is a director of clinical biostatistics at Merck & Co., Inc. Her research interests include survival and longitudinal data modeling, missing data imputation, cancer Phase I and II designs, repeated categorical data modeling, surrogate marker evaluations, adaptive design methodologies and implementations, and methods for benefit-risk assessment. Dr. He has published extensively in the areas of adaptive designs and benefit-risk evaluations and is the author of more than 50 peer-reviewed publications in statistical and medical journals. She is also a lead editor of the book Practical Considerations for Adaptive Trial Design and Implementation. She has been actively involved in many professional activities and services, including serving as co-chair of the Quantitative Sciences in the Pharmaceutical Industry (QSPI) Benefit-Risk Working Group, co-chair of the DIA Adaptive Design Scientific Working Group (ADSWG) KOL lecture series, associate editor for Statistics in Biopharmaceutical Research, and a referee for other statistical journals.

作者簡介(中文翻譯)

江琦博士是安進（Amgen）全球生物統計科學的執行董事。在這個角色中，她是腫瘤學和血液學的生物統計治療領域負責人，以及安全性和效益風險卓越中心的負責人。此外，江博士還負責監督安進在亞太地區的生物統計工作。在加入安進之前，她曾在哈佛公共衛生學院、默克（Merck）和諾華（Novartis）工作。江博士是Chapman & Hall/CRC書籍《藥物開發安全性定量評估：設計、分析與報告》的共同編輯，並且在方法開發、研究設計和數據分析與報告方面發表了超過60篇同行評審的出版物。她是美國統計協會的會士、美國統計協會生物製藥部門安全工作組的共同負責人、製藥行業定量科學（QSPI）效益風險工作組的共同負責人，以及《生物製藥研究中的統計學》的副編輯。

何維莉博士是默克公司（Merck & Co., Inc.）的臨床生物統計學主任。她的研究興趣包括生存和縱向數據建模、缺失數據插補、癌症I期和II期設計、重複類別數據建模、替代標記評估、自適應設計方法及其實施，以及效益風險評估的方法。何博士在自適應設計和效益風險評估領域發表了大量的研究，並在統計和醫學期刊上發表了超過50篇同行評審的出版物。她還是書籍《自適應試驗設計與實施的實用考量》的主編之一。她積極參與許多專業活動和服務，包括擔任製藥行業定量科學（QSPI）效益風險工作組的共同主席、DIA自適應設計科學工作組（ADSWG）KOL講座系列的共同主席、《生物製藥研究中的統計學》的副編輯，以及其他統計期刊的審稿人。

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