Comparison of Clinical PET Trial Between Taiwan and U.S.-A Preliminary Report

比較臺灣與美國正子臨床試驗申請之初探

張文議(Wen-Yi Chang) ； 高潘福(Pan-Fu Kao) ； 黃雅瑤(Ya-Yao Huang) ； 黃文盛(Wen-Sheng Huang)

《核子醫學暨分子影像雜誌》 33卷2期 (2020/06) Pp. 67-79

https://doi.org/10.6332/ANMMI.202006_33(2).0001

摘要

Remarkable progress in clinical applications of nuclear medicine theranostics has prompted a significant increase in global demand for positron emission tomography (PET) radiopharmaceuticals (drugs), such as the USA. Washington University School of Medicine has received a 5 years' project with US $ 6.3 million of financial support from National Institutes of Health since 2018 and establishes the PET-Radiotracer Translation & Resource Center (PET-RTRC) to provide assistance in the development and clinical trials of new PET drugs in the USA. Additionally, they hold related workshops to meet the objects of PET-RTRC. The workshops were only opened to domestic researchers in the past; however, it was opened to foreign participants in 2020. Because the USA and Europe policies for development and clinical use of PET drugs are always important references for Taiwan researchers working in nuclear medicine fields, we attended the PET-RTRC workshop this year and collected the latest information, which includes current US regulations/bylaws in compounding and clinical trials of PET new drugs, the procedures of documental applications and facility requirements of on-site preparation of PET drugs, as well as the differences between current regulatory situations of Taiwan and the USA.

關鍵字

nuclear medicine theranostics ； PET-RTRC ； regulations of clinical trials and compounding of PET drugs

並列摘要

近年來，核醫分子診療學（theranostics）在臨床應用上，有顯著進展，促使全球正子藥物的臨床需求大幅增加，包括美國。聖路易絲州華盛頓大學醫學院（Washington University School of Medicine）在2018年接受了美國國家衛生研究院（National Institutes of Health）的5年計畫，共630萬美元經費，成立正子藥物技術轉移與資源中心（Positron Emission Tomography-Radiotracer Translation & Resource Center），提供臨床正子新藥之開發與臨床試驗輔導，並舉辦相關研討會，以落實中心目標。此會議原僅開放美國國內相關單位參與，今年特地開放國外單位包括臺灣參加，臺灣正子藥物之研發與臨床應用均向歐美看齊，核醫學會與臺灣迴旋加速器學會因其重要性派員參與，藉以吸取最新相關訊息。藉由此次研習會參與之所得，本文即主要為整理並介紹現行美國正子藥物調製與臨床試驗的各項法規，申請流程與現場設施設備之觀摩，亦可以與我國現狀比較異同。

並列關鍵字

核醫分子診療學 ； 正子藥物技術轉移與資源中心 ； 正子藥物調製與臨床試驗法規