2015-05-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/711346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，整合國内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，也能與國内的製藥、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。本計晝聯合國内11家醫院之感染症專家與3研究中心的微生物 學家共20位，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、協助國内產業新產品 之研發上市、並支持由研究者自行發起之相關臨床研究。在過去的一年中，已參與了 8個跨國多中 心臨床試驗、3個國内廠商生技產品之相關臨床試驗、與三個由研究者所發起之臨床試驗，成效卓 著。未來將設法招募更多醫院加入本試驗聯盟，建構更加完整之臨床試驗平台，便利各項感染症相 關生技產品之臨床試驗進行。<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. We have establish the Taiwan Clinical Trial Consortium of Infectious Diseases by integrate infectious diseases specialists from 11 Taiwanese hospitals and microbiologists from 3 basic science research centers (20 experts in total) to make Taiwan become more competitive in participating international multicenter clinical trials. Our consortium have participated 8 international, multicenter clinical trials, 3 clinical trials sponsored by domestic biotechonological companies, and three investigator-initiated clinical studies in the past year. Our consortium has a great achievement. In the coming year, we will try to include more hospitals to join our consortium and create a well-designed platform for clinical trials to facilitate the conduction of various clinical trials related to the products of biotechonological companies relevant to infectious diseases.臨床試驗感染症試驗聯盟clinical trialsinfectious diseasestrial consortium