頁籤選單縮合
題名 | 教學醫院成立中藥臨床試驗中心=Clinical Trial Center for Traditional Chinese Medicine, China Medical University Hospital |
---|---|
作者 | 蔡長海; | 書刊名 | 中醫藥年報 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(102)1-(102)48 |
分類號 | 414.53 |
關鍵詞 | 藥品優良臨床試驗準則; 中藥臨床試驗; 吳茱萸湯; 查核; Good clinical practice; Traditional Chinese medicine clinical research; Wu-Chu-Yu Tang; Inspection; |
語文 | 中文(Chinese) |
中文摘要 | 本中心係於民國 90年起接受行政院衛生署中醫藥委員會的補助所成立,目標為提供符合國際法規協和會 (International Conference on Harmonization, ICH)所制訂藥品優良臨床試驗準則 (Good Clinical Practice, GCP)要求之臨床試驗場所和人員,建構高品質的中醫藥臨床試驗管理模式,以持續推動並促進中醫藥研究發展。 為了達到研究目的,本中心實際執行工作項目說明如下:(一)中藥臨床試驗之執行;(二)積極拓展中醫新藥開發研究;(三)建構臨床試驗諮詢服務系統;(四)臨床試驗課程之持續規劃;(五)建立臨床試驗品質保證制度。 在中藥臨床試驗之執行方面: 102年度中心執行 2件中藥療效再評估臨床試驗計畫案,計畫一「隨機、雙盲、對照組研究有關吳茱萸湯對胃食道逆流疾病之療效評估」達成收案數 90名,計畫二「隨機、雙盲、對照組研究有關黃耆對腦中風後患者疲勞之療效評估」預計收案共 90名,目前皆持續執行中;在積極拓展中醫新藥開發研究方面:透過學校產學合作處建立院、校合作機制,獲得與生技新藥公司發展中醫新藥研發機會;在建構臨床試驗諮詢服務系統方面:中心於 98年 5月因組織架構調整,而再度將網站作全面設計並陸續更新, 102年度至今諮詢服務網部分協助藥廠或受託研究機構可行性評估共計 86件;在臨床試驗教育訓練課程之持續規劃方面: 102年度本院舉辦及派員參與內部臨床試驗教育訓練課程目前為止共計 9場,鼓勵並派遣中心人員參與院外舉辦之臨床試驗教育訓練課程目前為止共計 4場;在建立臨床試驗品質保證制度方面: 102年度本中心已研擬並修訂 36項標準作業流程,召開中心一般性會議及計畫主持人會議,接受 1次本院臨床試驗中心試驗監測小組監測,接受每年 1次衛生署中醫藥委員會中藥新藥 GCP查核。本中心已整合中藥與新藥臨床試驗中心人力與物力資源,希望建構整合型管理模式與系統,以提升本院臨床試驗中心之運作效率,強化本中心執行臨床試驗之能量,期許提供試驗主持人與廠商高品質的服務,及提供中草藥研發更臻健全的試驗環境。 |
英文摘要 | This center was established with the subsidy granted by the Committee on Chinese Medicine and Pharmacy, Department of Health, Executive Yuan since 2001. The objectives are to provide the clinical trial site and personnel which meet the Good Clinical Practice (GCP) formulated by the International Conference on Harmonization (ICH) and to construct a high quality clinical trial management mode for Traditional Chinese medicine and pharmacy so as to promote and facilitate the research and development of Traditional Chinese medicine. In order to achieve the purposes of the research, the actual implementations of work of this center are as follows: (1) the implementation of Traditional Chinese medicine clinical trial; (2) active expansion of the research and development of new drugs of Traditional Chinese medicine; (3) construction of the consulting services system for clinical trial; (4) continued planning for clinical trial course; (5) establishment of quality assurance system for clinical trial. For the implementation of Traditional Chinese medicine clinical trial: in 2013, this center received 2 drug efficacy re-assessment clinical trial projects. The project "Randomized, double blind, placebo control trial to evaluate the efficacy of Wu-Chu-Yu Tang on gastroesophageal reflux disease (GERD)" completed recruiting 90 subjects. The project " Randomized, double blind, placebo control trial to evaluate the efficacy of Astragalus membranaceus in the patients after stroke with fatigue " expected to recruit 90 subjects. These two projects are currently being implemented. For the active expansion of the research and development of new drugs of Traditional Chinese medicine: Our Office of Industrial Academic Cooperation established hospital-school cooperation mechanisms, and obtained the opportunities of cooperating with the biotech and new pharmaceutical companies, in research and development of Chinese medicine. For the construction of consulting services system for clinical trial: in May, 2009, this center redesigned and updated the website because of organization structure revision. Since 2013, consulting services network provided 86 feasibility evaluations for pharmaceutical factories or contract research organizations so far. For continued planning for clinical trial course: in 2013, this center organized and sent representatives to participate in 9 internal clinical trial education training courses. This center encouraged and sent staff to participate in 4 clinical trial education training courses organized by external institutions. For the establishment of quality assurance system for clinical trial: in 2013, this center drafted and amended 36 standard operating procedures, held general center meetings and trial investigator meetings. This center was monitored for once by the monitoring group of this clinical trial center and was inspected once per year by the Traditional Chinese medicine new drug GCP of the Committee on Chinese Medicine and Pharmacy, Department of Health. Our center has integrated the personnel and material resources in the center for clinical study in Chinese pharmacy and novel drugs, and expect that the integrative management model and system is able to be constructed, in order to elevated the operation efficiency in the clinical study center in our hospital and then strengthen the energy for our center to perform clinical. It is expected to provide a high quality of service to the trial investigators and companies, and to provide a more robust trial environment for the research and development of Traditional Chinese herbal medicine. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。