2014-05-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/656706摘要：抗微生物製劑問世之後，原本以為感染性疾病將獲得完全控制。然而，事實並非如此；微生物的抗藥性隨抗微生物製劑的廣泛使用迅速增加，侵襲性治療與免疫抑制療法更使得感染症難以處理。截至目前為止，感染症仍是臨床上極為重要且困難處理的課題。為了對抗微生物的抗藥性，妥善使用現存的抗微生物製劑、研發新的抗微生物製劑、研發新的診斷工具、以及研發疫苗以增加宿主的抵抗力從而避免感染的發生，在在都是必需的。然而，為了加速上述產品、治療方式的推動上市，並釐清其臨床意義與治療效果，進行臨床試驗是當然需要的手段與方法。 為了有效推動感染症相關的臨床試驗，整合國內感染症相關研究量能、形成一臨床試驗聯盟，不僅能有更高的機會吸引跨國際製藥、生技、疫苗公司注意，讓台灣感染症界有機會更全面的參與跨國、多中心、新產品相關的臨床試驗，也能與國內的製藥、生技、疫苗產業更緊密的結合，加速相關新產品的自行研發與臨床試驗。本計畫擬聯合國內 10家醫院之感染症專家與 3研究中心的微生物學家，組成台灣感染症臨床試驗聯盟，積極參與跨國多中心臨床試驗、協助國內產業新產品之研發上市、並支持由研究者自行發起之相關臨床研究。 <br> Abstract: As the development and marketing of antimicrobial agents, some experts had predicted that the infectious diseases would be under control and even eradicated. However, this is not the truth. Infectious diseases become more and more difficult to manage because of rapid increased drug resistance among important pathogens after the overuse of antimicrobial agents and introduction of invasive procedures as well as immunosuppression therapy. Till now, treatment of infectious diseases remains the important clinical issues with great challenge. To overcome the drug resistance, wisely using the currently available antimicrobial agents, development of new antimicrobial agents and diagnostic tools, and introduction of new vaccines to increase hosts’ immunity and to protect the immunized hosts against active diseases are all necessary strategies. However, to facilitate the marketing of new antimicrobial agents, vaccines, and diagnostic tools and to confirm their efficacies, conducting relevant clinical trials are mandatory. Establishing a clinical trials consortium of infectious diseases is an important method to facilitate the conduction of related clinical studies. A consortium can attract international pharmaceutical, biotechnology, and vaccine companies to perform international, multicenter clinical trials on new products related to infectious diseases in Taiwan, help domestic companies conduct new drug clinical trials, and also support researchers initiated clinical studies. The present program intends to establish the Taiwan Clinical Trial Consortium of Infectious Diseases by integrate infectious diseases specialists from 10 Taiwanese hospitals and microbiologists from 3 basic science research centers to make Taiwan become more competitive in participating international multicenter clinical trials. This consortium will also help Taiwan companies to conduct new products clinical trials and support the researchers initiated clinical studies.抗微生物製劑問世之後，原本以為感染性疾病將獲得完全控制。然而，事實並非 如此；微生物的抗藥性隨抗微生物製劑的廣泛使用迅速增加，侵襲性治療與免疫抑制 療法更使得感染症難以處理。截至目前為止，感染症仍是臨床上極為重要且困難處理 的課題。為了對抗微生物的抗藥性，妥善使用現存的抗微生物製劑、研發新的抗微生 物製劑、研發新的診斷工具、以及研發疫苗以增加宿主的抵抗力從而避免感染的發生， 在在都是必需的。然而，為了加速上述產品、治療方式的推動上市，並釐清其臨床意 義與治療效果，進行臨床試驗是當然需要的手段與方法。 為了有效推動感染症相關的臨床試驗，整合國內感染症相關研究量能、形成一臨 床試驗聯盟，不僅能有更高的機會吸引跨國際製藥、生技、疫苗公司注意，讓台灣感 染症界有機會更全面的參與跨國、多中心、新產品相關的臨床試驗，也能與國內的製 藥、生技、疫苗產業更緊密的結合，加速相關新產品的自行研發與臨床試驗。本計畫 擬聯合國內 10家醫院之感染症專家與 3研究中心的微生物學家，組成台灣感染症臨床 試驗聯盟，積極參與跨國多中心臨床試驗、協助國內產業新產品之研發上市、並支持 由研究者自行發起之相關臨床研究。As the development and marketing of antimicrobial agents, some experts had predicted that the infectious diseases would be under control and even eradicated. However, this is not the truth. Infectious diseases become more and more difficult to manage because of rapid increased drug resistance among important pathogens after the overuse of antimicrobial agents and introduction of invasive procedures as well as immunosuppression therapy. Till now, treatment of infectious diseases remains the important clinical issues with great challenge. To overcome the drug resistance, wisely using the currently available antimicrobial agents, development of new antimicrobial agents and diagnostic tools, and introduction of new vaccines to increase hosts’ immunity and to protect the immunized hosts against active diseases are all necessary strategies. However, to facilitate the marketing of new antimicrobial agents, vaccines, and diagnostic tools and to confirm their efficacies, conducting relevant clinical trials are mandatory. Establishing a clinical trials consortium of infectious diseases is an important method to facilitate the conduction of related clinical studies. A consortium can attract international pharmaceutical, biotechnology, and vaccine companies to perform international, multicenter clinical trials on new products related to infectious diseases in Taiwan, help domestic companies conduct new drug clinical trials, and also support researchers initiated clinical studies. The present program intends to establish the Taiwan Clinical Trial Consortium of Infectious Diseases by integrate infectious diseases specialists from 10 Taiwanese hospitals and microbiologists from 3 basic science research centers to make Taiwan become more competitive in participating international multicenter clinical trials. This consortium will also help Taiwan companies to conduct new products clinical trials and support the researchers initiated clinical studies.sorafenibhepatocellular carcinomatransportergadoxetic acid-enhancedmagnetic resonance imaging