2012-05-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/647775摘要：慢性病毒性肝炎及肝細胞癌影響國人健康甚鉅，如何預防及治療仍有許多問題亟待解決。舉例而言，雖然經由全國B 型肝炎疫苗接種已經成功預防國人99%青少年以及嬰幼兒的B 型肝炎病毒感染，在成年人B 型肝炎帶原率仍高達12−20%，而且僅30-50%患者可透過現有抗病毒藥物加以控制，不易根除。約30%慢性C 型肝炎無法藉由目前標準治療根治。肝細胞癌是國內最常見的肝臟惡性腫瘤，每年約有2000 人新診斷個案，但除了少數早期患者可以接受手術根治性切除以外，目前對此癌症欠缺有效的治療方法。此外，非酒精性脂肪肝病和藥物引發肝傷害將成為國內重要肝臟疾病，需要積極研究及預防處理。雖然國內已有許多專家學者投入肝臟疾病的研究並獲得不錯的成果，僅以個人或單一家醫院要進行臨床試驗收案速度將極為緩慢，能收集的組織檢體也很有限。為了加速新藥及新醫療器材之臨床試驗以及相關研究的進展，成立國內肝炎及肝細胞癌臨床試驗合作聯盟有其迫切性。我們在新開展「行政院國家科學委員會生技醫藥國家型科技計畫」下申請資源中心計畫，建立台灣肝炎及肝癌之臨床試驗合作聯盟[Taiwan-LiverNet Consortium (TLC)]，以協助研究者及產業界推動肝病相關臨床研究及試驗。本計畫同時收集臨床檢體，以應未來轉譯醫學研究之需。在第一年計畫中，我們首先結合北部(臺大醫院總院暨雲林分院、台北榮總、國泰醫院、亞東醫院、仁愛醫院、慈濟醫院台北分院、基隆長庚醫院、及林口長庚醫院)、中部(中國醫藥大學附設醫院、台中榮總、及中山醫學大學附設醫院)、南部(高雄長庚醫院及高雄醫學大學附設醫院)以及東部(慈濟醫院花蓮總院)等各大醫學中心成立臨床試驗核心，並整合基礎研究、統計學、病理學、流行病學、以及資料庫管理等各領域專家協助試驗合作聯盟之運作、資料組織庫管理、和未來轉譯研究的進行。我們已建立一個標準流程有系統地自各合作醫院收集肝病病人的臨床、病理及流行病學的相關資料及臨床檢體，並據此將建立一個大型的資料庫及血清檢體庫，未來可提供全國的研究學者申請使用。我們預期三年期間主導或協助推展5-10 個臨床試驗或研究的進行(第一年計畫中已主導5 個臨床試驗/研究)，收集約1000 個肝病患者(第一年計畫中已收集約200 個肝病患者)，並收集約1000-2000 個臨床檢體(第一年計畫中已收集約30 個臨床檢體)。這些臨床資料和檢體，將會定期由各醫院助理和資料處理中心人員完成資料的處理並放入電腦中。我們利用ezTrial 系統來處理任何與資料有關的問題，如資料的取得、新增、更新、刪除、彙整與統計運算，建立一個資料倉儲(data warehousing)，以便能為研究人員提供一致性的資料。此外我們也已經建立一個網頁，公開廣泛介紹本試驗合作聯盟之架構、成員、功能及運作方式。未來將進一步設計次網頁及聯結，讓有興趣研究者可以對這個資料庫有所了解。當檢體收集數目超過1000個時，我們將成立一個由著名專家組成的使用者委員會(User Committee)，定期審查並決議提供資料及檢體給有興趣研究者。我們相信這是國內一個大型針對肝疾病所成立的試驗合作聯盟，結合各大醫學中心及研究機構內所有對肝病研究有興趣的基礎和臨床學者成立一個研究網絡 (research network)，協助進行試驗主持人所發起的臨床試驗，並加速國內產業界對新藥、新器材的早期研發工作。本合作聯盟試驗之成效以及透過網頁之宣傳，也將有效吸引國際大藥廠來本土進行新藥、新器材的投資。我們同時將建立肝病的資料庫及檢體庫，相信對台灣肝病的轉譯研究將會有極大的助益。<br> Abstract: Chronic viral hepatitis B and C and the related liver diseases (liver cirrhosis andHCC) are still major health problems in Taiwan. Furthermore, after the eradication ofchronic viral hepatitis, nonalcoholic fatty liver diseases and drug-induced liver injurywill become the next most common etiology of liver diseases in Taiwan. Overall, we,as physician scientists, have the mission to solve these important health problemsthrough the development of new drug/device and the conduction of translationalresearches. Thus investigator-initiated clinical studies/trials as well asnoninvestigator-initiated studies/trials supported by local or internationalbio-pharmaceutical companies are needed.Current problems in conduction of clinical trials or translational researchesinclude: (1) inadequate interactions between basic and clinical researchers, or amongclinical researchers, certain new information or new products could not beincorporated into clinical trials; (2) lack of novel idea, the young clinical investigatormay have difficulty in identifying important issues to be addressed; (3) difficult toidentify cooperative team, lack of a research network for collection of clinical patientsand samples; (4) difficult to collect, store and manage data and serum/PBMC samples;(5) for translational researches, lack of input and cooperation from basic scientists;and (6) for clinical trials, lack of research resources support, including researchassistants, laboratory support, preparation of IRB process, etc. Besides, there are nowmany strong competitors in the Asia-Pacific region. Without cooperation, therecruitment of patients will be slow, and the competitive edge will be low. Thus weurgently need to establish a research network for liver diseases in Taiwan to helpincorporating and facilitating the related research and development activities. Theresolution of certain clinical issues actually can be accomplished through thedevelopment of a cooperative team or consortium composed of clinical investigatorsand experts in various aspects of biomedical researches. To solve the aforementionedproblems, we develop “Development of Hepatitis and Hepatocellular CarcinomaClinical Trial Consortium in Taiwan” (abbreviated as Taiwan-LiverNet Consortium[TLC]).In the first-year project, we successfully form a consortium for conduction ofclinical trials and develop the platform for collection of serum/PBMC bank for futuretranslational research. We already conduct 5 investigator-initiated clinicalstudies/trials, collect 200 study patients, and collect 30 serum bio-samples. Wedevelop a webpage demonstrating the organization, composition and function of theconsortium. Our consortium members also actively support several multicenterclinical trials sponsored by local or international biopharmaceuticals.Through this platform, clinicians can translate any novel idea into clinical trials,can easily identify the research partners, and the complicated process of trialincluding IRB application can also be settled. We establish an efficient and productiveresearch team to solve important liver problems in Taiwan, and to promote theresearch activity and academic performance. Next, we can provide clinical samplesfor translational research. At the same time, the network will cooperate with local orinternational pharmaceutical company to develop new drugs or devices. Furthermore,through the propagation of our consortium in website, more investment, either locallyor internationally, on liver diseases-related new drug and device will be attracted intoTaiwan.We believe that after the development of the consortium, the following long-termobjectives will be achieved, including promotion of Taiwan liver research to be one ofthe world leaders, acceleration of the new drug or device developed by local Taiwanpharmaceuticals for liver diseases, provision of clinical samples for futuretranslational research in liver diseases, and promotion of the health of Taiwanesepeople by reducing liver-related morbidity and mortality.台灣肝炎肝癌臨床試驗合作聯盟轉譯醫學Taiwanhepatitishepatocellular carcinomatrialconsortiumtranslational research