COVID-19疫情對臨床試驗法規及實務因應之探討

自2019年底爆發嚴重特殊傳染性肺炎 (下稱COVID-19)迄今，全球疫情嚴峻且尚未完全平息，各產業領域及經濟活動受到嚴重的衝擊，改變人類的工作與生活模式。我國於今(2021)年5月爆發本土疫情全國提升為三級警戒，雖疫情相較各國控制得當，但疫苗未達群體免疫警戒仍未解除，僅能維持民生及基本經濟活動能量。國內生技醫藥產業與國際藥廠具高度密切關聯性及互動，因此受到國際疫情牽動影響，尤其臨床試驗是新藥或新疫苗研發階段不可或缺的環節，而我國臨床試驗與醫藥先進國共同執行之多國多中心試驗計畫占國內比例多數，各國自疫情流行以來，執行臨床試驗過程面臨著許多不確定性和廣泛的挑戰，如受試者的招募及返診、試驗藥品的供給及試驗偏差增加等，導致全球許多臨床試驗被迫中斷或延後。美國FDA、歐盟EMA、日本PMDA，及數個醫藥先進國政府單位均迅速採取法規鬆綁的應對措施，針對疫情危機發布執行臨床試驗的指導原則及建議，供試驗相關利益者參循。政府、生技醫藥產業及醫療機構等單位，皆以保障受試者安全及權益為首要考量下，提供更多彈性策略，如受試者返診以電話或視訊替代實體面對面進行、結合數位工具進行遠端監測或虛擬化模式設計試驗等，將執行臨床試驗過程的影響層面降到最低，兼顧受試者權益並避免延宕新藥開發時程。爰此，本研究針對COVID-19疫情衝擊下對臨床試驗於法規面及實務面之影響進一步探討，藉由蒐集各國主管機關發布之相關指引或建議，並分析臨床試驗執行現況，以提供未來我國臨床試驗因應與實務執行之參考。

關鍵字

COVID-19 ；臨床試驗；遠距醫療；去中心化試驗

並列摘要

Since the outbreak of Severe Pneumonia with Novel Pathogens (hereafter referred to as COVID-19) in late 2019, the global epidemic has been severe and has not yet been fully controlled, with serious impacts on various industrial sectors and economic activities, changing the work and life patterns of human beings. Although the epidemic in dosmetic is well-controlled compared to other countries, the vaccine has not yet reached the level of herd immunity and can only maintain the livelihood and basic economic activities. The domestic biotechnology and pharmaceutical industries are highly interconnected and interactive with international pharmaceutical companies, and are therefore affected by the international epidemic, especially since clinical trials are an integral part of the development of new drugs or vaccines. Since the epidemic, many clinical trials around the world have been interrupted or delayed due to uncertainties and challenges, such as the progress of subjects recruitment and visits, delivery of investigational medicinal products, and increased trial deviations. The U.S. FDA, EU EMA, Japan PMDA, and regulatory authority of several advanced countries have taken prompt countermeasures, but the safety of subjects remains the primary concern of the authorities. The government, biotechnology and pharmaceutical industries, and medical institutions are all moving toward providing more flexible strategies that do not affect the rights of subjects, such as using telephone or video-based methods for subject visits instead of physical face-to-face, and using digital tools for remote monitoring or virtualized trial model , in order to minimize the impact of clinical trials, protect the rights of subjects, and avoid delays in the development and marketing of new drugs. Therefore, this study focuses on the impact of the COVID-19 epidemic on the implementation of clinical trials in the global regulatory and practical aspects, and collects relevant guidelines or recommendations issued by the competent authorities of various countries as a reference for the response and implementation of clinical trials in Taiwan.