執行分散式臨床試驗之倫理考量

Ethical Consideration in Conducting Decentralized Clinical Trials

蔡甫昌(Daniel Fu-Chang Tsai) ； 胡嘉輝(Kar-Fai Foo)

《台灣醫學》 28卷1期 (2024/01) Pp. 68-80

https://doi.org/10.6320/FJM.202401_28(1).0009

摘要

臨床試驗經常面臨研究結果之可推論性（generalizability）及招募對象代表性不足之疑慮，研究方法須針對此問題進行調整方能持續精進。2020年起歷時3年多的新冠肺炎全球大流行，也顯露出臨床試驗以醫學中心為基礎而執行之中心化模式恐有所不足。發展「真實世界數據」分析及「分散式臨床試驗」等概念於是受到更多重視與發展。本文指出傳統臨床試驗有所不足之處、介紹真實世界數據研究及分散式臨床試驗之內涵與特色、執行分散式臨床試驗涉及之研究倫理考量，並提出相關實務建議。

關鍵字

分散式臨床試驗 ； 真實世界證據 ； 研究倫理

並列摘要

Clinical trials often face concerns about the generalizability of research results and insufficient representation of recruited subjects. Research methods must be adjusted to address these issues to continue to improve. The global COVID-19 pandemic that has lasted for more than three years since 2020 has also revealed that the centralized model of clinical trials based on medical centers may be insufficient. Concepts such as "real-world data" analysis and "decentralized clinical trials" have received more attention and development. This article explores the limitations of conventional clinical trials, introduces the features of real-world evidence and decentralized clinical trials, and analyzes possible ethical issues while utilizing decentralized clinical trials. Finally, several practical recommendations are proposed.

並列關鍵字

decentralized clinical trials ； real-world evidence ； research ethics

參考文獻

Gaudino M, Arvind V, Hameed I, et al. Effects of the COVID-19 pandemic on active non-COVID clinical trials. J Am Coll Cardiol 2020;76:1605-6. https://doi.org/10.1016/j.jacc.2020.07.051

McDermott MM, Newman AB. Preserving clinical trial integrity during the coronavirus pandemic. JAMA 2020;323:2135-6. https://doi.org/10.1001/jama.2020.4689

McDermott MM, Newman AB. Remote research and clinical trial integrity during and after the coronavirus pandemic. JAMA 2021; 325:1935-6. https://doi.org/10.1001/jama.2021.4609

Brown DG, Wobst HJ. A decade of FDA-approved drugs (2010-2019): Trends and future directions. J Med Chem 2021;64:2312-38. https://doi.org/10.1021/acs.jmedchem.0c01516

Martin L, Hutchens M, Hawkins C, et al. How much do clinical trials cost?. Nat Rev Drug Discov 2017;16:381-2. https://doi.org/10.1038/nrd.2017.70