篇名

臨床試驗法規─新時代的挑戰   免費試閱

並列篇名

Regulatory Science in Clinical Trials-Challenges of the New Era

作者
中文摘要

新藥、新醫療器材和新醫療技術須經過臨床試驗,才有機會核准上市並納入醫療常規。新藥研發過程需經過三個階段的試驗,而第三期隨機分配的臨床試驗長久以來是公認的黃金標準,通常新成分藥需要兩個樞紐試驗才能新藥查驗登記,但是藥價也因為研發時程冗長而居高不下。美國國家衛生院向來有強力支持多中心臨床試驗團體的機制,由癌症研究院提供人事及行政經費,新藥及研究者自行發起臨床試驗的經費,因此主導了整個全世界癌症醫療指引及癌症用藥的新藥研發。近年來,免疫治療的崛起、精準醫學的潮流勢不可擋。在個人化醫療、精準醫療的時代,第114屆美國國會在2016年底通過21世紀治癒法案,其中美國食品藥物管理局被賦予改革新藥查驗登記流程的使命。在可見的未來我們將會看到臨床試驗法規的重大變革,而臺灣臨床試驗法規要如何演進,才能既保有彈性又具有科學性基礎及嚴謹度,則有待產、官、學各方集思廣益。

英文摘要

New drug, new medical device, and new medical technology should be validated through clinical trials. Especially new drug development needs to go through the phase I, II, III trials, which ends up the ever increasing development budget and leading to higher and higher drug cost. Year 2016 is the year of immunotherapy, and precision medicine is an overwhelming trend. The US National Institute of Health has strong support of investigatorinitiated-trials. National Cancer Institute provided ample funding to oncologic cooperative groups, which leads to change of guidelines and many new drug approvals. The 21st Century Cures Act is a US law enacted by the 114th United States Congress in December 2016. The 21st Century Cures Act called to modify the FDA drug approval process. It was intended to expedite the process by which new drugs and devices are approved by easing the requirements put on drug companies looking for FDA approval on new products or new indications on existing drugs. Where should we go in this new regulatory trend led by the US? New drug regulation need evolution. How to maintain flexibility and scientific stringency in formulation of regulations mandate the stakeholders to collaborate with open and novel thoughts.

起訖頁

044-051

出版單位
DOI

10.3966/241553062017080010004  複製DOI  DOI查詢

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