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中山醫學大學附設醫院-西藥、醫材暨新醫療技術臨床試驗中心Chung Shan Medical University Hospital-New Drug, New Medical Device, New Medical Technology Clinical Trial Management Center

  • Total Beds1,134
  • Total Doctors483
  • AddressNo.110，Sec.1，Jianguo N.Rd.，South,Taichung City 402
  • ContactMiss Liu
  • Emailcshgcrc@csh.org.tw
Link to Hospital Link to Clinical Trial Center

1. Provide one stop shop service window

2. Online contract reviewing system.

3. Regularly hold clinical trial education training courses

Site Introduction

In order to improve the research quality, Chung Shan Medical University Hospital (CSMUH) has established the New Drug, New Medical Device, New Medical Technology Clinical Trial Management Center in 1995, which was also named General Clinical Research Center (GCRC). We have a variety of well-experienced research teams with first-rate investigators in all fields of medical service and health provision. We all adhered strictly to the ICH-GCP and regulatory guidelines of Taiwan. We have excellent record that some principal investigators have succeeded in the official inspections by the TFDA Taiwan, the PMDA Japan and the FDA USA. We have been awarded the lead center to conduct the project of 「Establishment of the Key Environment for the Development of Good Clinical Trial」with excellent performance. We offered many clinical training courses in research ethics, sciences, regulations and GCP. We also invited a variety of experts, including disinterested community members, volunteer associations, industry, academic representatives and governmental authorities. We not only proposed every one with the proposed excellent training curriculum for everyone, but also presented each person with the comprehensive, novel, and practical clinical trial and human research related information.In order to encourage the cooperation between the outstanding investigators of our institution and the representatives of pharmaceutical industries, we invited them to discuss regularly. On the basis of TFDA regulations, we have played the good role of Site Management Organization (SMO), as well as have signed the contracts with several big pharmaceutical companies to establish and promote the excellent key environment in carrying out high quality clinical trials.

Clinicl Trial Expertise

Drugs, foods, cosmetics, edicinal products, post-marketing monitoring

International Accreditation

GCP Inspection/audit

PMDA

 

US FDA

What types of clinical trial do you conduct?

Spotlights

CTC

The Food and Drug Administration of the Ministry of Health and Welfare awarded the award for the "103 Multi-Center Integration and Quality and International Competitiveness Enhancement Project for the Implementation of New Drug Clinical Trials in Medical Institutions".

The Department of Health of the Executive Yuan commended the Center for its efforts to implement the "Improving the Key Environment for Comprehensive Drug Testing in Clinical Trials". It will contribute to improving the research and development efficiency of new drugs in the domestic biotechnology industry and safeguarding people's lives.

The clinical trial plan of "Vortioxetine for daily medical practice for patients with severe depression in Asia-Taiwan study (TREVIDA) (plan number: 18150N; our hospital case number: CS2-19025)" Since August 2008, he has taken over as the chief moderator of the Taiwan Regional Test Plan.

The hospital's Department of Oncology, Dr. Wu Mingfang, performed “A randomized, double-blind, double-dummy, parallel group, international multicenter study assessing the efficacy and safety of a netupitant-palonosetron Fixed Dose Combination (FDC) compared to an extemporary combination of granisetron and aprepitant on the prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with cancer” (program ID: NETU-12-07; our hospital case number: CS13172), since July, 104 Taking over as the chief moderator of the Taiwan Regional Test Plan, the value is affirmative.

 

The hospital's Department of Oncology, Dr. Wu Mingfang, performed “A randomized, double-blind, double-dummy, parallel group, international multicenter study assessing the efficacy and safety of a netupitant-palonosetron Fixed Dose Combination (FDC) compared to an extemporary combination of granisetron and aprepitant on the prevention of highly emetogenic chemotherapy-induced nausea and vomiting in patients with cancer” (program ID: NETU-12-07; our hospital case number: CS13172), since July, 104 Taking over as the chief moderator of the Taiwan Regional Test Plan, the value is affirmative.

Publications

CTC

1

Wu MF, Chuang CY, Lin P, Chen WT, Su SE, Liao CY, Jan MS, Chang J*. Lung tumorigenesis alters the expression of Slit2-exon15 splicing variants in tumor microenvironment. Cancers Feb 1 2019, 11(2), 166; doi:10.3390/cancers11020166

2

Wu MF1,2, Wu CH3, Chen CW4, Lin YS5, Chen DC5*and Ko JL2, 3* Effect of Ling Zhi-8 supplementation on docetaxel-induced leukopenia and thrombocytopenia in patients with advanced non-small cell lung cancer. Chung Shan Medical Journal 2018; 29:123-132中山醫誌

3

Nfor ON, Wu MF, Lee CT, Lee W, Liu WH, Tantoh DM, Hsu SY, Lee KJ, Ho CC, Debnath T, Lung CC, Liaw YP. Body mass index modulates the association between CDKAL1 rs10946398 variant and type 2 diabetes among Taiwanese women. Sci Rep. 2018 Sep 5;8(1):13235 (SCI JCR 2017, IF 4.122 MULTIDISCIPLINARY SCIENCES

4

Shin IL, Hsu JC, Wu WJ, Lu HJ, Wu MF (co-correspondence), Ko JL. GMI, a fungal immunomodulatory protein from Ganoderma microsporum, induce apoptosis via β-catenin suppression in lung cancer cells. Environmental Toxicology 2018 Sep;33(9):955-961

5

Lee MY, Wu MF, Cherng SH, Chiu LY, Yang TY, Sheu GT. Tissue transglutaminase 2 expression is epigenetically regulated in human lung cancer cells and prevents reactive oxygen species-induced apoptosis. Cancer Management and Research, 2018 Aug 23;10:2835-2848

6

Nfor ON, Wu MF, Debnath T, Lee CT, Lee W, Liu WH, Tantoh DM, Hsu SY, Liaw YP. Hepatitis B virus infection in Taiwan: The role of NTCP rs2296651 variant in relation to sex. J Viral Hepat. 2018 Apr 16:1-5.

7

Wu CH, Hsiao YM, Yeh KT, Tsou TC, Chen CY, Wu MF (co-correspondence), Ko JL. Upregulation of microRNA-4417 and Its Target Genes Contribute to Nickel Chloride-promoted Lung Epithelial Cell Fibrogenesis and Tumorigenesis. Sci Rep. 2017 Nov 10;7(1):15320

8

Kuo WT, Tu DG, Chiu LY, Sheu GT, Wu MF (correspondence). High pemetrexed sensitivity of docetaxel-resistant A549 cells is mediated by TP53 status and down regulated thymidylate synthase. Oncology Reports 2017 Nov 38(5): 2787- 2795

9

Wu MF, Liao CY, Wang LY, Chang JT. The role of Slit-Robo signaling in the regulation of tissue barriers. Tissue Barriers. 2017 Apr 3; 5(2): e1331155. Epub 2017 Jun 8

10

Shen WC, Chen JS, Shao YY, Lee KD, Chiou TJ, Sung YC, Rau KM, Yen CJ, Liao YM, Liu TC, Wu MF, Lee MY, Yu MS, Hwang WL, Lai PY, Chang CS, Chou WC, Hsieh RK. Impact of Undertreatment of Cancer Pain With Analgesic Drugs on Patient Outcomes: A Nationwide Survey of Outpatient Cancer Patient Care in Taiwan. J Pain Symptom Manage. July 2017, 54 (1) 55–65

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