放射性藥物之臨床試驗面面觀

精準醫學與各項癌症新穎療法的相關研究大幅崛起，而隨著技術進步，放射藥物的重要性也逐漸展現。為促進放射藥物開發，美國與歐洲皆已有完整的放射藥物相關法規。近來，臺灣相關規範也在努力當中，尤其新藥臨床試驗（investigational new drug, IND）相關法規，例如2021年新修訂的「核醫放射性藥品臨床試驗基準」，以及提出的「診斷用造影劑之臨床研發策略指導原則」皆已成為放射藥物開發中非臨床藥毒理試驗以及臨床試驗評估設計的重要指引。然而，自2017年起放射新藥研究和其臨床試驗數目不斷增加，也有越來越多放射診斷新藥陸續被引進臺灣，但是學研機構之醫學研究者往往因為人力與資源有限，以及藥品臨床試驗申請繁瑣，往往對於藥品臨床試驗的執行視為畏途，尤其是研究者自行發起之臨床試驗（investigator-initiated trial）。因此，本篇文章旨於簡介全球和臺灣放射藥物發展現況，並根據過往經驗將放射藥物臨床試驗申請流程簡化為三階段八步驟，以期讓越來越多醫學研究者更瞭解IND申請流程，進而促進臺灣新型放射藥物之開發。

關鍵字

放射藥物；臨床試驗；精準醫療；癌症

並列摘要

Studies on precision medicine and novel therapeutics for various types of cancer have surged. Advancements in these technologies have revealed the importance of radiopharmaceuticals. The United States and Europe have established comprehensive regulatory frameworks to promote the development of radiopharmaceuticals. In Taiwan, efforts have been made to formulate relevant regulations, particularly regulations of investigational new drugs (INDs). For instance, ＂Clinical Trial Benchmarks for Radiopharmaceuticals in Nuclear Medicine＂ (revised in 2021) and the proposed ＂Guidelines for Clinical Development Strategies of Diagnostic Contrast Agents＂ are important guidelines in the development of radiopharmaceuticals for non-clinical toxicology drug testing and the design and evaluation of clinical trials. Since 2017, increasing numbers of radiopharmaceutical studies and clinical trials have been conducted, and new diagnostic radiopharmaceuticals have been introduced in Taiwan. However, researchers at academic institutions often regard clinical trials of drugs, especially investigator-initiated trials, as perilous undertakings because of limited labor and resources and complicated clinical trial applications. Therefore, herein we report the current status of radiopharmaceutical development both in Taiwan and the rest of the world and present a simplified application procedure for radiopharmaceutical clinical trials based on our experience, with three stages and eight steps, to improve the understanding of IND applications among medical researchers, thereby promoting the development of new radiopharmaceuticals in Taiwan.

並列關鍵字

cancer ； clinical trials ； precision medicine ； radiopharmaceuticals

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