摘要:在過去幾年內,我們已進行並完成一些研究者自行發起之國內多中心乳癌臨床試驗案。以目前的合作基礎,我們將聯合國內十家醫學中心,包括台大醫院,台北榮總,三軍總醫院,馬偕醫院,林口長庚醫院,台中榮總,彰化基督教醫院,高醫附設醫院,高雄榮總,以及和信治癌醫院,建立乳癌臨床試驗案本資源中心。此資源中心將建立乳癌臨床試驗試驗平台,及臨床檢體,臨床資料收集之平台。此平台之建立將有利於創造出更多高水準之本土多中心臨床試驗,爭取國際藥廠與我國合作。此平台之建立亦將有助於支持台灣本土藥廠或研究機構所開發之新藥開發研究在最後一關臨床試驗。關於乳癌臨床資料的收集及檢題的收集更有助於台灣各項的重要的學術研究的發展資源。本計畫所收集之臨床資料及檢體將可提供國內許多大型學術研究計劃使用,或在各項研究初步完成後,做為confirmation study 的資源供應,亦可提供國內新藥研發機構或藥廠做為臨床前研究之資源所需。本計畫之價值在提升台灣乳癌多中心臨床試驗的水準,執行效率,執行能力,建立品牌效應以提高國際競爭力,建立臨床試驗平台以提供國內新藥研發的最終臨床試驗的支持。
Abstract: During the past years, our team, Department of Oncology and Department of Surgery (formed a functional unit: Breast Cancer Center), National Taiwan University Hospital, had initiated many breast cancer clinical trial, including multi-center clinical trial. Currently, there are three investigator-initiated multi-center breast cancer clinical trial ongoing, including phase I/II study, Phase II with pharmacodynamics and functional image study, and Phase III randomized study. We and our co-workers from other medical center have also been involved in many important international clinical trials, and our effort and credibility have been recognized. Besides, our team members have also been recognized as opinion leader in the field of breast cancer treatment in Asia Pacific region.Base of our current multi-center clinical trial connection, we plan to organize a Taiwan Clinical Trial Consortium - Breast Cancer (TCTC-BC), in order to provide technical and consultation platforms for further improve the productivity of this network. At beginning, this consortium will involve 10 medical centers, including: National Taiwan University Hospital, Taipei Veteran General Hospital, Taichung Veteran General Hospital, Kaohsiung Veteran General Hospital, Changhua Christian Hospital, Mackay Memorial Hospital, Chang-Gung Memorial Hospital, Tri-Service General Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital, and Koo Fundation Su Yat-Sen Cancer Center. By establishing this joint research group, we could perform high quality, well coordinated clinical trials on new anti-breast cancer drugs in Taiwan. We will also collaborate with many multinational pharmaceutical and biotechnology companies, as well as research institutions, in oncology clinical trials for breast cancer.Specific aims1. Development and conduction of high quality multi-center new drug clinical trial in Taiwan.2. Become leading group for evaluating new therapeutic strategies in breast cancer in the Asia-Pacific region.By establishing this consortium, we plan to 1.) facilitate the conduction and improve the quality of current ongoing multi-center clinical trials; 2.) development of new multi-center clinical trial; 3.) establish a platform to assist principle investigator initiated multicenter clinical trial, provide statistic consultation, logistic support; 4.) establish a resource center for clinical trial data collection, sample collection and management, collaborate with chemical and bio-specimen bank to preserve and service the usage of these material; 5.) intermediate service for new drug clinical trial of Taiwan; 6.) intermediate service for international clinical trial. cancer clinical trials and provide the expertise to interact with the industry in terms of drug development and clinical trial design and conduction. TCTC-BC will provide services to academic partners to evaluate concept for drug development and finding or confirmation of therapeutic target or other investigation. TCTC-BC is important in the future competition with other Asian countries in breast cancer clinical trial business.