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完整後設資料紀錄
DC 欄位 | 值 | 語言 |
---|---|---|
dc.contributor.advisor | 李素華 | zh_TW |
dc.contributor.advisor | Su-Hua Lee | en |
dc.contributor.author | 唐楚揚 | zh_TW |
dc.contributor.author | Cassidy Tang | en |
dc.date.accessioned | 2023-12-20T16:31:04Z | - |
dc.date.available | 2023-12-21 | - |
dc.date.copyright | 2023-12-20 | - |
dc.date.issued | 2023 | - |
dc.date.submitted | 2023-11-20 | - |
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Retrieved June 18, 2023, from https://www.research.nhg.com.sg/wps/wcm/connect/romp/nhgromp/02+ethics+and+quality/apply+ethics+approval/understand+ethics+review+processs No place like home? Stepping up the decentralization of clinical trials. (2021, June 10) . McKinsey & Company. Retrieved Auguest 12, 2023, https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials Olivier, J. (2022, February 22) . Taiwan’s Clinical Trials Landscape Weathers the COVID Era - Taiwan Business TOPICS. Taiwan’s Clinical Trials Landscape Weathers the COVID Era - Taiwan Business TOPICS. Retrieved from https://topics.amcham.com.tw/2022/02/taiwans-clinical-trials-landscape-weathers-covid-era/ Outsourcing Drug Development. (2005, August 22) . Contract Pharma. Retrieved from https://www.contractpharma.com/issues/2002-10/view_features/outsourcing-drug-development/ Sathian, B., Asim, M., Banerjee, I., Pizarro, A. B., Roy, B., Van Teijlingen, E. R., Nascimento, I. J. B. D., & Alhamad, H. K. (2020, September 30) . Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal Journal of Epidemiology, 10 (3) , 878–887. https://doi.org/10.3126/nje.v10i3.31622 Shah, N. (2004, June) . Pharmaceutical supply chains: key issues and strategies for optimisation. Computers & Chemical Engineering, 28 (6–7) , 929–941. https://doi.org/10.1016/j.compchemeng.2003.09.022 Shimizu, T., Kim, D., Loong, H. H., Lin, C., Ng, M. C., Yamamoto, N., Ma, B., & Tan, D. S. (2021, January 27) . Overcoming the impact of the COVID‐19 pandemic on oncology early phase trials and drug development in Asia—Experiences and perspectives of the Asian Oncology Early Phase 1 Consortium. Asia-Pacific Journal of Clinical Oncology. https://doi.org/10.1111/ajco.13510 Straus, M. (2022, March 10) . CRO Update: Where are Contract Research Organizations Headed? Applied Clinical Trials Online. 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Zhou, "Drug Governance: IoT-based Blockchain Implementation in the Pharmaceutical Supply Chain," 2020 Sixth International Conference on Mobile And Secure Services (MobiSecServ) , Miami Beach, FL, USA, 2020, pp. 1-8, doi: 10.1109/MobiSecServ48690.2020.9042950. 藥品優良臨床試驗作業準則. (n.d.) . 全國法規資料庫. Retrieved April 23, 2023, from https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0030056 人體試驗管理辦法. (n.d.) . 全國法規資料庫. Retrieved April 23, 2023, from https://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=L0020162 人體生物資料庫管理條例. (n.d.) .全國法規資料庫. Retrieved May 01, 2023, from https://law.moj.gov.tw/LawClass/LawAll.aspx?PCode=L0020164 人體研究法. (n.d.) .全國法規資料庫. Retrieved May 01, 2023, from https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0020176 個人資料保護法. (n.d.) . 全國法規資料庫. Retrieved April 23, 2023, from https://law.moj.gov.tw/LawClass/LawHistory.aspx?pcode=I0050021 王志嘉. (2020, February 1) . 人體研究、人體試驗、臨床試驗的定義與內涵-兼談細胞治療的現況與展望. Taiwan Medical Journal, 63 (2) , 27–32. https://www.tma.tw/ltk/109630206.pdf 黃元辰 (民110) 。COVID-19 疫情對臨床試驗法規及實務因應之探討。碩士論文,國立臺灣大學生物科技管理碩士在職學位學程,臺北市。 藥品技術性資料審查. (n.d.) . 財團法人醫藥品查驗中心. Retrieved May 1, 2023, from https://www3.cde.org.tw/drugs/ 電子版香港法例. (n.d.) . Hong Kong e-Legislation. Retrieved June 18, 2023, from https://www.elegislation.gov.hk/hk/cap138A!zh-Hant-HK 臨床試驗CRO公司老總告訴我們的幾件事 (上) :產業分類 | 案件類型 | 發展趨勢. (2023, March 8) . 台灣光鹽生物科技學苑. https://www.biotech-edu.com/臨床試驗cro公司老總告訴我們的幾件事上/ 【臨床研究】國內c-IRB審查機制送審與實務經驗分享 - 暘氏手札. (2023, February 11) . 暘氏手札. Retrieved August 12, 2023, from https://yang-notes.com/c-irb/ | - |
dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/91329 | - |
dc.description.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。 | zh_TW |
dc.description.abstract | 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. | en |
dc.description.provenance | Submitted by admin ntu (admin@lib.ntu.edu.tw) on 2023-12-20T16:31:04Z No. of bitstreams: 0 | en |
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dc.description.tableofcontents | 口試委員會審定書 #
誌謝 i 中文摘要 ii ABSTRACT iv CONTENTS vi LIST OF FIGURES & TABLES viii 第一章 緒論 1 第一節 研究背景 1 第二節 研究目的 4 第三節 研究架構 5 第二章 全球醫藥產業臨床研究現況 7 第一節 臨床試驗起源 (歷史性回顧) 7 第二節 全球醫藥臨床研究發展現況 (試驗藥品運輸、生醫藥品製造) 10 第三節 臨床研究委託機構在促進醫藥產業發展中的關鍵作用 16 第四節 臨床研究委託機構近年發展 21 第三章 亞太國家臨床試驗環境與規範 29 第一節 亞太國家臨床試驗環境及法規 (新加坡、台灣) 31 第一項 台灣臨床試驗送審機制 31 第二項 新加坡臨床試驗送審機制 42 第二節 外商臨床研究委託機構在台灣執行臨床試驗之困境- 個案訪談結果 54 第四章 COVID-19疫情之臨床試驗環境改變 59 第一節COVID-19疫情下臨床試驗之困局 59 第二節 COVID-19疫情間臨床試驗環境及法規改變 64 第三節 COVID-19疫情後臨床試驗環境及法規改變 74 第四節 分散式/去中心化 (Decentralized Clinical Trials, DCT) 臨床試驗我國推動的現況與難處 78 第五章 結論與建議 82 第一節 結論 82 第二節 建議 84 REFERENCES 87 訪談附錄 90 個案訪談紀錄1 93 個案訪談紀錄2 95 個案訪談紀錄3 97 | - |
dc.language.iso | zh_TW | - |
dc.title | 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 | zh_TW |
dc.title | Exploring the Current State of Clinical Trial Environment and Clinical Research Organizations (CROs) and their Challenges Amidst the COVID-19 Pandemic | en |
dc.type | Thesis | - |
dc.date.schoolyear | 112-1 | - |
dc.description.degree | 碩士 | - |
dc.contributor.oralexamcommittee | 吳全峰;張濱璿 | zh_TW |
dc.contributor.oralexamcommittee | Chuan-Feng Wu;Pin-Hsuan Chang | en |
dc.subject.keyword | 臨床試驗,臨床研究委託機構,COVID-19, | zh_TW |
dc.subject.keyword | Clinical trial,Contract Research Organization (CRO),COVID-19, | en |
dc.relation.page | 98 | - |
dc.identifier.doi | 10.6342/NTU202304416 | - |
dc.rights.note | 同意授權(全球公開) | - |
dc.date.accepted | 2023-11-21 | - |
dc.contributor.author-college | 進修推廣學院 | - |
dc.contributor.author-dept | 生物科技管理碩士在職學位學程 | - |
顯示於系所單位: | 生物科技管理碩士在職學位學程 |
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