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本平台目的為推廣台灣臨床試驗，提供廠商、研究者及一般民眾臨床試驗之相關訊息。 若您需要刊登受試者招募廣告、臨床試驗相關活動或臨床試驗受托機構訊息，歡迎留下您的資料與聯絡方式，我們會儘速跟您連繫。
若有臨床試驗設計規劃上的諮詢需求，歡迎至財團法人醫藥品查驗中心(CDE)網站的諮詢輔導專區，填寫資料後送出，會有專人與您連繫。
高雄醫學大學附設中和紀念醫院-臨床試驗中心KMUH Clinical Trial Center
1. 高醫大附設醫院於2018通過第二次AAHRPP評鑑，且於2023通過第三次JCI評鑑。
2. 國內第一個成立脊髓肌肉萎縮症團隊治療的醫院
3. 台灣第一個受衛福部核可「進行臉部移植手術」的臨床試驗單位。
臨床試驗中心簡介
高雄醫學大學附設中和紀念醫院除臨床病人照護之外，為提高醫療照護與研究水準以迎上國際腳步，長期以來即投資大量的人力、物力及空間於臨床試驗，與多家國內外大藥廠、科學園區、金屬工業研究發展中心簽訂合作協議，為國內臨床試驗及醫材研究發展的重鎮之一。除臨床試驗團隊外，本院結合實證醫學統計中心及卓越檢驗中心，共同為臨床試驗團隊提供進一步宏觀的支持。
臨床試驗重點領域
肝炎、大腸直腸癌、乳癌、肺癌、脊髓肌肉萎縮症
國際認證
Full accredited from the AAHRPP in Dec, 2018 and , Mar 2022
3th accredited by Joint Commission International (JCI) in Mar, 2023
3th accredited by Joint Commission International (JCI) in Mar, 2023
GCP查核
In 2010/5 and 2016/7, the clinical trial team of Prof. Wan-Long Chuang was approved by US FDA
2015/5, Protocol # HGS1008-C1067, Alfa-2b(alb-IFN)
2016/7, Protocol # GS-US-320-0108, TAF, GS-7340/Viread®
2015/5, Protocol # HGS1008-C1067, Alfa-2b(alb-IFN)
2016/7, Protocol # GS-US-320-0108, TAF, GS-7340/Viread®
卓越亮點
CTC
於疫情期間，以全視訊模式，進行第三次JCI評鑑，並通過。
國內第一個成立脊髓肌肉萎縮症團隊治療的醫院
健康/疾病資料庫
CTC
| 資料庫 | 疾病類別 | 2016年 | 2017年 | 2018年 | 總計 | 備註說明 |
| Nephrology： | Pre-ESRD | 1,562 | 1,611 | 1,816 | 4,989 | Pre-ESRD末期腎臟病前期病患登錄/定期返診人數 |
| Hepatology： | Hepatitis B | 495 | 517 | 511 | 1,523 | Hepatitis B 健保用藥登錄人數 |
| Hepatitis C | 145 | 356 | 531 | 1,032 | Hepatitis C 健保用藥登錄人數 | |
| Hepatitis B+C | 640 | 873 | 1,042 | 2,555 | Hepatitis B、C 健保用藥登錄人數 | |
| Diabetes： | Diabetes | 11,043 | 11,151 | 10,479 | 32,673 | DM藥物治療/定期返診(2次) 人數 |
| Diabetes+衛教 | 5,309 | 6,282 | 6,965 | 18,556 | DM藥物治療/定期返診(2次) & DM衛教人數 | |
| Cancer Databases： | Cancer | 4,061 | 4,144 | NA | 8,205 | 癌症登錄人數 (依癌數計之) |
| Cardiology： | Atrial Fibrillation | 2,597 | 2,725 | 3,236 | 8,558 | 心房顫動(AF) 門診確診人數 |
| Acute Myocardial Infarction | 1,577 | 1,670 | 1,898 | 5,145 | 急性心肌梗塞(AMI) 門診確診人數 | |
| AF+AMI | 4,174 | 4,395 | 5,134 | 13,703 | AF、AMI門診確診人數 | |
| Health | Health | 16 | 19 | 31 | 66 | 健康受試者人數 |
近年文獻發表
CTC
1
Thompson, G. R., Soriano, A., Cornely, O. A., Kullberg, B. J., Kollef, M., Vazquez, J., ... & Zhang, Y. (2023). Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial. The Lancet, 401(10370), 49-59.
2
Estephan, L., Lin, Y. C., Lin, Y. T., Chen, Y. H., Pan, S. C., Hsieh, S. M., ... & Lien, C. E. (2023). Safety and immunogenicity of homologous versus heterologous booster dose with AZD1222, mRNA-1273, or MVC-COV1901 SARS-CoV-2 vaccines in adults: An observer-blinded, multi-center, phase 2 randomized trial. Vaccine, 41(23), 3497-3505.
3
Zhou, C., Tang, K. J., Cho, B. C., Liu, B., Paz-Ares, L., Cheng, S., ... & Girard, N. (2023). Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. New England Journal of Medicine, 389(22), 2039-2051.
4
Tsai, H. L., Lin, C. C., Sung, Y. C., Chen, S. H., Chen, L. T., Jiang, J. K., & Wang, J. Y. (2023). The emergence of RAS mutations in patients with RAS wild-type mCRC receiving cetuximab as first-line treatment: a noninterventional, uncontrolled multicenter study. British Journal of Cancer, 129(6), 947-955.
5
Huang, C. W., Hu, H. M., Hsu, W. H., Chen, C. Y., Huang, M. Y., Chen, C. P., ... & Wang, J. Y. (2023). A phase Ib/II trial of PEP503 (NBTXR3, radioenhancer) with radiotherapy and chemotherapy in patients with rectal cancer. Nanomedicine, 18(6), 511-524.
6
Tsai, H. L., Shi, H. Y., Chen, Y. C., Huang, C. W., Su, W. C., Chang, T. K., ... & Wang, J. Y. (2023). Clinical and cost-effectiveness analysis of mFOLOFX6 with or without a targeted drug among patients with metastatic colorectal cancer: inverse probability of treatment weighting. American Journal of Cancer Research, 13(9), 4039.
7
Tsai, H. L., Shi, H. Y., Chen, Y. C., Huang, C. W., Su, W. C., Chang, T. K., ... & Wang, J. Y. (2023). Clinical and cost-effectiveness analysis of mFOLOFX6 with or without a targeted drug among patients with metastatic colorectal cancer: inverse probability of treatment weighting. American Journal of Cancer Research, 13(9), 4039.
8
Chiang, N. J., & Chen, L. T. (2023). Adjuvant therapy in biliary tract cancers: oral fluoropyrimidine as a beginning. The Lancet, 401(10372), 170-171.
9
Hsieh, C. C., Su, Y. C., Jiang, K. Y., Ito, T., Li, T. W., Kaku-Ito, Y., ... & Shen, C. H. (2023). TRPM1 promotes tumor progression in acral melanoma by activating the Ca2+/CaMKIIδ/AKT pathway. Journal of Advanced Research, 43, 45-57.
10
Wong, Y. J., Tran, S., Huang, C. F., Hsu, Y. C., Preda, C., Toyoda, H., ... & Nguyen, M. H. (2023). Real-world treatment outcome with protease inhibitor direct-acting antiviral in advanced hepatitis C cirrhosis: a REAL-C study. Hepatology International, 1-12.