2017-05-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/655533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，促進產學合作，更能有較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。在個人與國內其它10 家醫院之感染症專家與3 研究中心的微生物學家共19 位，所組成的台灣感染症臨床試驗聯盟，於2014 年初步成立運轉，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；至今，已參與了20 個跨國多中心臨床試驗、9 個國內廠商生技產品之相關臨床試驗、與4 個由研究者所發起之臨床試驗，在臨床試驗的參與進行上，已初具規模。未來在本研究計畫進行期間，將以此為基礎，設法招募更多醫院加入本試驗聯盟以提高臨床試驗量能，並通過各種標準化流程的制訂來建構更加完整之臨床試驗平台；以此參與更多，特別是國內自行研發之新產品所相關的，臨床試驗，提升台灣感染症臨床試驗之研究水準，促進產學合作。<br> Abstract: As the development and marketing of antimicrobial agents, some experts had predicted that theinfectious 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 drugresistance among important pathogens after the overuse of antimicrobial agents and introduction ofinvasive procedures as well as immunosuppression therapy. Till now, treatment of infectious diseasesremains the important clinical issues with great challenge. To overcome the drug resistance, wiselyusing the currently available antimicrobial agents, development of new antimicrobial agents anddiagnostic tools, and introduction of new vaccines to increase hosts’ immunity and to protect theimmunized hosts against active diseases are all necessary strategies. However, to facilitate themarketing 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 facilitatethe conduction of related clinical studies. A consortium can help domestic companies and attractinternational pharmaceutical, biotechnology, and vaccine companies conduct necessary clinical trialsrelated to their new drug, devices, or diagnostic kits related to infectious diseases in Taiwan. Theconsortium also can support researchers initiated clinical studies. We have establish the Taiwan ClinicalTrial Consortium of Infectious Diseases by integrate infectious diseases specialists from 11 Taiwanesehospitals and microbiologists from 3 basic science research centers (19 experts in total) to make Taiwanbecome more efficient in conducting domestic clinical trials and more competitive in participatinginternational multicenter clinical trials. Our consortium have participated 20 international, multicenterclinical trials, 9 clinical trials sponsored by domestic biotechnological companies, and 4investigator-initiated clinical studies in the past year. Our consortium has a great achievement. In thefollowing years with the support of the present project, we will try to include more hospitals to join ourconsortium and create a well-designed platform for clinical trials to facilitate the conduction of variousclinical trials related to the products of biotechnological companies relevant to infectious diseases.臨床試驗感染症試驗聯盟clinical trialsinfectious diseasestrial consortium