臨床試驗環境與臨床研究委託機構 (CRO) 現狀及在 COVID-19疫情下的挑戰之探討

Abstract

臨床試驗在醫學研究領域中的歷史可以追溯到數百年前。其主要目的是評估新藥物、治療方法或醫療產品的安全性和有效性，以確保對人類健康的益處。自18世紀開始，臨床試驗在醫學研究中一直扮演著至關重要的角色。然而，過去的臨床試驗並未像現代試驗一樣受到嚴格的倫理和法規監管與控制。直到20世紀，隨著倫理和法規的進步，臨床試驗才逐漸變得更加嚴謹。在過去的幾十年裡，臨床試驗歷經了巨大的發展和變革。隨著科技的進步和對人權意識抬頭，藥品臨床試驗的保護要求也不斷提高，試驗設計和實施在此之下變得更加精確和可靠。此外，國際間的合作和訊息交流也促進臨床試驗的全球化。近年來，生物科技產業的蓬勃發展使得臨床試驗變得更加多樣化和專業化。許多專門的臨床研究機構 (Contract Research Organization, CRO) 成立，為製藥公司和學術機構提供臨床試驗的專業服務。COVID-19疫情也對臨床試驗產生了深遠的影響，迫使業界結合時下熱門科技探索分散式臨床試驗和遠端監控等新模式，以應對疫情所帶來的挑戰並確保試驗的進行。臨床試驗行業仍在不斷變化和進步中，致力於提供更安全、高效和創新的試驗方式，以推動醫療科技的發展和人類健康的進步。 因此，本文旨在探討在COVID-19疫情前後，臨床研究委託機構對於臨床試驗環境和法規的影響，並提供建議以應對未來可能的挑戰。研究方法將以「文獻分析法」及「次級資料」為基礎，透過蒐集整理國內外相關的文獻資料，了解臨床試驗環境在疫情前與後的改變以及臨床研究委託機構於亞太區對臨床試驗環境的影響。將先闡述臨床研究委託機構近年發展，再探討COVID-19疫情後臨床研究委託機構角色的調整，並進一步瞭解在台灣外商臨床研究委託機構所面臨的困境及法規與主管機關的影響。整合訪談內容，探討法律制定下對臨床試驗在台灣遇到的情況和挑戰，並分析台灣推動分散式臨床試驗的現況與難處，以及後疫情時代台灣臨床試驗的遠程目標，希望透過這些探討和分析，幫助台灣臨床試驗行業將更好地適應未來的挑戰，為推動醫療科技的發展和人類健康的進步不斷努力。

Clinical trials have a long history in the field of medical research, dating back hundreds of years. Their primary purpose is to assess the safety and efficacy of new drugs, treatment methods, or medical products to ensure their benefits to human health. Since the 18th century, clinical trials have played a crucial role in medical research. However, in the past, these trials were not subject to the same rigorous ethical and regulatory controls as modern trials. It was only in the 20th century that clinical trials gradually became more rigorous with advancements in ethics and regulations. In the past few decades, clinical trials have undergone significant development and transformation. Advancements in technology and an increasing awareness of human rights have led to higher standards of protection for human subjects, making trial design and implementation more precise and reliable. Additionally, international collaboration and information exchange have facilitated the globalization of clinical trials. Furthermore, the booming biotechnology industry in recent years has made clinical trials more diverse and specialized. Many specialized Contract Research Organizations (CROs) have been established to provide professional services for clinical trials to pharmaceutical companies and academic institutions. The outbreak of the COVID-19 pandemic presented unprecedented challenges globally, including in the field of clinical trials. To adapt to these challenges, the industry has explored new models such as decentralized clinical trials and remote monitoring, leveraging popular technologies, to ensure the continuation of trials. The clinical trial industry continues to evolve and strive to provide safer, more efficient, and innovative ways of conducting trials to drive medical technology development and improve human health. Therefore, the aim of this article is to explore the impact of Contract Research Organizations on the clinical trial environment and regulations before and after the COVID-19 pandemic and provide recommendations to address potential future challenges. The research method will be based on "document Analysis " and "secondary data," collecting and organizing relevant domestic and international literature to understand the changes in the clinical trial environment before and after the pandemic and the impact of CROs on the clinical trial environment in the Asia-Pacific region. The article will first elaborate on the recent developments of CROs, then examine the role adjustments of CROs after the COVID-19 pandemic, and further explore the challenges and regulatory influence faced by foreign CROs in Taiwan. By integrating interview content, the article will discuss the situations and challenges of clinical trials in Taiwan under legal regulations, analyze the current status and difficulties of promoting decentralized clinical trials in Taiwan, and explore the remote goals of Taiwan's clinical trials in the post-pandemic era. Through these discussions and analyses, the article aims to assist the clinical trial industry in Taiwan in better adapting to future challenges, continually striving to drive the development of medical technology and improve human health.