Real-World Evidence in Medical Product Development

本書提供了最先進的統計方法、來自監管機構和贊助商的實際考量、物流以及實踐者在採用實務證據/數據（RWE/D）方面的真實案例。隨機臨床試驗一直是評估醫療產品療效和安全性的黃金標準。然而，成本、持續時間、實用性和有限的普適性促使許多人尋求優化藥物開發的替代方法。本書將全面列舉與採用RWE/D相關的各個方面，包括但不限於在監管和非監管環境中的應用、因果推論方法、組織和基礎設施考量、物流挑戰以及實際案例。

Weili He

Dr. Weili He has over 25 years of experience working in the biopharmaceutical industry. She is currently a Distinguished Research Fellow and head of Medical Affairs and Health Technology Assessment statistics at AbbVie. She has a PhD in Biostatistics. Weili's areas of expertise span across clinical trials, real-world studies and evidence generations, statistical methodologies in clinical trials, observational research, innovative adaptive designs, and benefit-risk assessment. She is the lead or co-author of more than 60 peer-reviewed publications in statistics or medical journals and lead editor of two books on adaptive design and benefit-risk assessment, respectively. She is the co-founder and co-chair of the American Statistical Association (ASA) Biopharmaceutical Section (BIOP) Real-world Evidence Scientific Working Group from 2018 to 2022. Weili is the BIOP Chair-Elect, Chair, and Past Chair from 2020-2022. She is also an Associate Editor of Statistics in Biopharmaceutical Research since 2014, and an elected Fellow of ASA since 2018.

Yixin Fang

After he received his PhD in Statistics from Columbia University in 2006, Yixin Fang had been working in academia before he joined AbbVie in 2019. Currently, he is a Research Fellow and Director of Statistics in Medical Affairs and Health Technology Assessment Statistics (MA&HTA Statistics) at AbbVie. Within MA&HTA Statistics, he is Head of the therapeutics areas (TAs) of Eye Care and Specialty and Head of Causal Inference Center (CIC). In this role, he is involved with the design and analysis of Phase IV studies and real-world studies in medical affairs and leading HTA submissions in the TA of Eye Care. In addition, he is active in the statistical community with over 100 peer-reviewed manuscripts and his research interests are in real-world data analysis, machine learning, and causal inference.

Hongwei Wang

Dr. Hongwei Wang has close to 20 years' experience working in the biopharmaceutical industry. He is currently a Research Fellow and Director at Medical Affairs and Health Technology Assessment Statistics of AbbVie. Prior to that, Hongwei worked at Sanofi and Merck with increasing responsibilities. He has been leading evidence planning and evidence generation activities across various therapeutic areas in the fields of real-world studies, network meta-analysis and post-hoc analysis with a mission to support medical affair strategy and optimal reimbursement. Hongwei received his PhD in Statistics from Rutgers University, conducts active methodology research and their applications to different stages of drug development. He serves as coauthor of about 40 manuscripts in peer reviewed journals and over 100 presentations at scientific congresses.

韋麗·何博士在生物製藥行業擁有超過25年的經驗。她目前是AbbVie的杰出研究員，並擔任醫學事務和健康技術評估統計學的負責人。她擁有生物統計學博士學位。韋麗的專業領域涵蓋臨床試驗、現實世界研究和證據生成、臨床試驗中的統計方法學、觀察性研究、創新的適應性設計和效益風險評估。她是60多篇統計或醫學期刊的主要或共同作者，並分別是兩本關於適應性設計和效益風險評估的書的主編。她是美國統計協會（ASA）生物製藥部（BIOP）現實世界證據科學工作組的聯合創始人和聯合主席，任期為2018年至2022年。韋麗是BIOP的當選主席、主席和前主席，任期為2020年至2022年。自2014年以來，她還擔任《生物製藥研究中的統計學》的副編輯，並自2018年起當選為ASA的會士。

方一新在2006年從哥倫比亞大學獲得統計學博士學位後，一直在學術界工作，直到2019年加入AbbVie。目前，他是AbbVie醫學事務和健康技術評估統計學（MA＆HTA統計學）的研究員和統計學主任。在MA＆HTA統計學中，他是眼科和專科治療領域的負責人，也是因果推論中心（CIC）的負責人。在這個角色中，他參與醫學事務中第四期研究和現實世界研究的設計和分析，並在眼科領域領導HTA提交。此外，他在統計學界非常活躍，發表了100多篇同行評審的論文，他的研究興趣包括現實世界數據分析、機器學習和因果推論。

王宏偉博士在生物製藥行業擁有近20年的經驗。他目前是AbbVie醫學事務和健康技術評估統計學的研究員和主任。在此之前，宏偉在Sanofi和默克擔任不同職責的工作。他一直在各種治療領域中領導證據規劃和證據生成活動，包括現實世界研究、網絡荟萃分析和事後分析，旨在支持醫學事務戰略和最佳報酬。宏偉在Rutgers大學獲得統計學博士學位，並積極從事方法研究及其在藥物開發的不同階段的應用。他是約40篇同行評審期刊的合著者，並在科學大會上發表了100多次演講。