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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。
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成大醫院臨床試驗中心National Cheng-Kung University Hospital Clinical Trial Center
1. 擁有完善早期臨床試驗相關設備及豐富執行經驗，包含506件第一、二期之早期臨床試驗。
2. 擁有專業研究護理師團隊及其完善職級分級.
3. 提供一站式專案媒合與管理服務模式
臨床試驗中心簡介
國立成功大學醫學院附設醫院臨床試驗中心為支持及管理臨床試驗的服務平台，有專業的試驗主持人、研究護理師和行政人員提供臨床試驗服務，以協助啟動臨床試驗及確保臨床試驗質量。
提供服務包括:
- 藥物、醫療器材之各期臨床試驗。
- 支持研究者自行發起臨床試驗。
- 提供臨床試驗教育訓練。
- 提供臨床試驗管理
- 研究可行性評估連絡窗口。
- 媒合臨床試驗主持人。
- 研究護理師/行政人力支援。
- 臨床試驗合約/預算管理。
臨床試驗重點領域
腫瘤(肺癌，肝癌，上消化道癌，血液腫瘤，實體腫瘤，泌尿癌，婦癌…), 腸胃肝膽,心血管,內分泌,神經,風濕免疫,精神,皮膚…
國際認證
Accreditation
- Full Accredited from the Association for the Accreditation of Human Research Protection Program (AAHRPP)
- Pharmacogenomics laboratory received accreditations from the Taiwan Accreditation Foundation (TAF)
- Pharmacogenomics laboratory received accreditations from the College of American Pathologists (CAP)
Training and Education
- Yearly trained with GCP and ACRP accreditation current regulation
GCP查核
No critical issues from Audit and Inspection
- Audits by the pharmaceutical companies and CROs.
- Inspections by TFDA, FDA
卓越亮點
CTC
近年文獻發表
CTC
1
Chloe Orkin et al(2024). Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials. All Science Journal Classifications, 11(2), 75-78. https://doi.org/10.1016/S2352-3018(23)00258-8
2
Margaret A. Tempero, et al(2023). Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results from a Randomized, Open-Label, Phase III Trial. Journal of Clinical Oncology, 41(11), 2007-2019. https://doi.org/10.1200/JCO.22.01134
3
Shubham Pant, et al (2023). Erdafitinib in patients with advanced solid tumours with FGFR alterations (RAGNAR): an international, single-arm, phase 2 study. The Lancet Oncology, 24(8), 925-935. https://doi.org/10.1016/S1470-2045(23)00275-9
4
R K Kelley,et al(2023). Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet, 401(1391), 1853-1865. https://doi.org/10.1016/S0140-6736(23)00727-4
5
A. T.C. Chan, et al(2023). Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial. Annals of Oncology, 34(3), 251-261. https://doi.org/10.1016/j.annonc.2022.12.007
6
S Y Rha, et al(2023). Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial. The Lancet Oncology, 24(11),1181-1195. https://doi.org/10.1016/S1470-2045(23)00515-6
7
Z Ren, et al(2023). Tislelizumab in Patients with Previously Treated Advanced Hepatocellular Carcinoma (RATIONALE-208): A Multicenter, Non-Randomized, Open-Label, Phase 2 Trial. Liver Cancer, 12(1), 72-84. https://doi.org/10.1159/000527175
8
Sara A. Hurvitz, et al (2023). Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial. The Lancet, 401(10371),105-117. https://doi.org/10.1016/S0140-6736(22)02420-5
9
M Simonelli, et al(2022). Isatuximab plus atezolizumab in patients with advanced solid tumors: results from a phase I/II, open-label, multicenter study. ESMO Open, 7(5), 100562. https://doi.org/10.1136/jitc-2021-003697
10
Peter Schmid, et al(2022). Abstract PD10-03: BEGONIA: Phase 1b/2 study of durvalumab (D) combinations in locally advanced/metastatic triple-negative breast cancer (TNBC): Results from Arm 1 D+ paclitaxel. Cancer Research, 82, PD10-03. https://doi.org/10.1158/1538-7445.SABCS21-PD10-03