臺灣臨床試驗受試者招募實務及規範之進程

Clinical Trials Subject Recruitment, Regulations and Considerations in Taiwan

吳倚晴(Yi-Ching Wu) ； 陳建煒(K. Arnold Chan)

《台灣醫學》 25卷6期 (2021/11) Pp. 843-851

https://doi.org/10.6320/FJM.202111_25(6).0016

摘要

受試者保護在臨床試驗的每一個環節，都應被詳加考慮及落實；考量受試者之招募過程對受試者是否參與試驗有直接、重大之關鍵影響，本文由受試者招募實務之環節作為切入點，並彙整國內外近年臨床試驗受試者招募相關實務及規範之演變，以受試者保護為出發點提出分析及建議。

關鍵字

受試者保護 ； 臨床試驗受試者招募 ； 受試者招募廣告 ； 潛在受試者

並列摘要

Protection of human research subject is crucial in clinical trials and should be carefully considered in every single step of a clinical trial. One important component in human subject protection is recruitment of potential clinical trial participants. In this article we reviewed the practical aspects of clinical trial subject recruitment from a human research protection perspective, considering the evolvement of relevant government guidance and regulations in Taiwan and latest global development as a result of advance in clinical trials methodology, changes in regulatory requirement in different countries, and utilization of information technology. We also made suggestions on practices of clinical trial teams and ethics review in Taiwan to support engagement in cutting edge clinical trials.

並列關鍵字

research subjects protection ； clinical trials subject recruitment ； advertisement for clinical trial subjects ； potential clinical trial subjects

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