請用此 Handle URI 來引用此文件：
http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/79692完整後設資料紀錄
| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 李素華(Su-Hua Lee) | |
| dc.contributor.author | Yuan-Chen Huang | en |
| dc.contributor.author | 黃元辰 | zh_TW |
| dc.date.accessioned | 2022-11-23T09:07:45Z | - |
| dc.date.available | 2021-09-13 | |
| dc.date.available | 2022-11-23T09:07:45Z | - |
| dc.date.copyright | 2021-09-13 | |
| dc.date.issued | 2021 | |
| dc.date.submitted | 2021-08-28 | |
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ICH, https://www.ich.org/. 52. no-place-like-home-stepping-up-the-decentralization-of-clinical-trials” June 10, 2021 McKinsey.com. 53. https://store.gbimonthly.com/Article/Detail/58775 54. https://www.businesswire.com/news/home/20210210005986/zh-HK/ 55. https://www.statnews.com/2018/09/21/clinical-trials-reinvention-janssen/ 56. antidote, “What clinical trial statistics tell us about the state of research today,” by Eian Kantor (September 10, 2020) See full resource here: https://bit.ly/34eN54J. 57. Clinical Leader, “Warming Up To Hybrid Trials,” by Rebecca McAvoy (February 3, 2021). See full resource here: https://bit.ly/34dA0Ja. 58. WHO Global Observatory for eHealth. (2010). Telemedicine: opportunities and developments in Member States: report on the second global survey on eHealth. 59. http://www.genetinfo.com/international-news/item/32242.html 60. GlobalData. (10Feb2021 ) Global oncology Phase II clinical trials heavily impacted by COVID-19 disruptions, says GlobalData. Retrieved July 22, 2021, https://www.globaldata.com/global-oncology-phase-ii-clinical-trials-heavily-impacted-covid-19-disruptions-says-globaldata/. 61. GlobalData. (10Jun2021 ) COVID-19 clinical trials have increased by 639% with the US leading the way. Retrieved July 22, 2021, https://www.globaldata.com/covid-19-clinical-trials-increased-639-us-leading-way/. 62. Nidhi Bajpai. August 12, 2020. Decentralized Clinical Trials: A Data Scientist's Perspective. https://www.hcltech.com/blogs/decentralized-clinical-trials-data-scientists-perspective. | |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/79692 | - |
| dc.description.abstract | 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。 | zh_TW |
| dc.description.provenance | Made available in DSpace on 2022-11-23T09:07:45Z (GMT). No. of bitstreams: 1 U0001-2508202100001700.pdf: 3050708 bytes, checksum: 7e8816133077fb8fea1899acce7d1555 (MD5) Previous issue date: 2021 | en |
| dc.description.tableofcontents | "口試委員會審定書 i 誌謝 v 中文摘要 vi ABSTRACT vii 第一章 緒論 1 第一節 研究背景 1 第二節 研究動機 2 第三節 研究目的 3 第四節 分析方法 4 第五節 研究流程 5 第二章 文獻回顧與探討 6 第一節 COVID-19之新型冠狀病毒崛起與介紹 6 第二節 臨床試驗 8 壹、 概述 8 貳、 我國藥品臨床試驗之管理架構與現況 9 參、 藥品優良臨床試驗規範(Good Clinical Trial Practice, GCP) 12 肆、 臨床試驗之利益關係者(Stakeholder) 13 伍、 COVID-19 疫情對臨床試驗之影響 14 第三節 遠距醫療(Telemedicine) 18 第四節 去中心化試驗(Decentralized Clinical Trials, DCT) 22 第三章 COVID-19疫情對臨床試驗法規面之探討 29 第一節 各國衛生主管機關對於疫情期間臨床試驗之因應措施 29 壹、 美國FDA 29 貳、 歐盟EMA 30 參、 英國MHRA 32 肆、 日本 PMDA 34 伍、 小結 35 第二節 台灣衛生主管機關對於疫情期間臨床試驗之因應 41 第四章 COVID-19疫情對臨床試驗實務面之探討 43 第一節 遠距醫療 居家訪診 Telemedicine Home Visit 43 第二節 試驗藥品交付Investigational Medicinal Products Delivery 44 第三節 電子同意書E-consent/E-ICF 45 第四節 遠端監測Remote monitoring 46 第五章 結論及建議 48 第一節 研究結論 48 第二節 未來建議 49 參考文獻 51" | |
| dc.language.iso | zh-TW | |
| dc.title | COVID-19疫情對臨床試驗法規及實務因應之探討 | zh_TW |
| dc.title | The Study of Clinical Trial on Regulation and Practice in COVID-19 Pandemic | en |
| dc.date.schoolyear | 109-2 | |
| dc.description.degree | 碩士 | |
| dc.contributor.oralexamcommittee | 吳全峰(Hsin-Tsai Liu),何佳安(Chih-Yang Tseng) | |
| dc.subject.keyword | COVID-19,臨床試驗,遠距醫療,去中心化試驗, | zh_TW |
| dc.subject.keyword | COVID-19,Clinical trial,Telemedicine,Decentralized Clinical Trials, | en |
| dc.relation.page | 55 | |
| dc.identifier.doi | 10.6342/NTU202102700 | |
| dc.rights.note | 同意授權(全球公開) | |
| dc.date.accepted | 2021-08-30 | |
| dc.contributor.author-college | 進修推廣學院 | zh_TW |
| dc.contributor.author-dept | 生物科技管理碩士在職學位學程 | zh_TW |
| 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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| U0001-2508202100001700.pdf | 2.98 MB | Adobe PDF | 檢視/開啟 |
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