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長庚紀念醫院林口臨床試驗中心Chang Gung Memorial Hospital, Linkou, Clinical Trial Center

  • Total Beds10,058
  • Total Doctors1,827
  • AddressNo. 5, Fuxing Street, Guishan District, Taoyuan City, 333Guishan,Taoyuan City 333
  • ContactHsiao-Ying Kuo, Administrative Chief
  • Emailhykuo0512@gmail.com
  • Phone Number+886-3-328-1200 ext 5146
Link to Hospital Link to Clinical Trial Center

1. Promotion of early phase clinical trials.

2. Promote the development of domestic and international biotechnology.

3. Promote education of clinical trial training.

Site Introduction

Northern Chang Gung Memorial Hospitals (CGMH) are much honored to be granted since 2009 to establish an excellent Clinical Trials and Center (CTC) in to foster clinical research by means of the highest ethical and scientific standards in a practical and cost-effective manner to promote new therapeutic discovery and validation. We have integrated clinical trials in CGMH at Linkou and Keelung, established space construction, hardware and software acquisition, personnel training, and standard operating procedures (SOPs) submitted for approval. We strived to (1) facilitate routes of communication between industry sponsorship and CGMH investigators; (2) provide the infrastructure for clinical research (personnel and facilities); (3) convene IRB consortium in excellent CTCs as well as the other medical centers; (4) promote key environments for international collaborations with academic institutions and industrial partnership; (5) and well communication of MOHW programs that include “Establishing an excellent cancer research center” and “Establishing an excellent clinical trial center”. 
In the 21st century, Taiwan will impress the world with its vast potential in medicine and biotechnology. Prospectively, national and international pharmaceutical companies, government research agencies and private sectors seeking academic medical centers to test new diagnostics and therapies will find that CGMHs have positioned themselves at the top of this new wave in clinical trials and translational research. We also assist phase III randomized trials of Asian Gynecologic Oncology Group, GCIG, NRG, and other international consortiums. Several young attending physicians will be sent to collaborative international medical centers for training.

Clinicl Trial Expertise

(1) facilitate routes of communication between industry sponsorship and CGMH investigators via "One-stop Shopping" by CTC;
(2) provide the infrastructure for clinical research (personnel and facilities) in all four CGMHs and prepare all CGMHs to pass the Amemrican Accreditation Human Research Protection Program (AAHRPP) accreditation;
(3) carry out molecular imaging, proton therapy (hepatoma trials will carry out gender difference analysis) and cell-base regenerative therapies and facilitate clinical validation of several useful biomarkers;
(4) promote key environments for international collaborations with academic institutions and industrial partnership; worked on harmonization between domestic medical centers and also top-4 medical Centers in China;
(5) set up a supportive system for CTC personals and build up competitive strength for Taiwanese investigators to be principal investigators (PI) of international multicenter trials.

International Accreditation

AAHRPP, FERCAP, JCI, HIMSS

http://www.chang-gung.com/en/about.aspx?id=98&bid=1

GCP Inspection/audit

US FDA, EMA

What types of clinical trial do you conduct?

Spotlights

CTC

The CTC of Chang Gung Medical Foundation is in order to assist the coordination of implementation and technical aspects of clinical trial in the branch of Taipei, Linkou, Taoyuan, and Tucheng, to ensure the quality of clinical trials、 strengthens biomedical translation research and the development of new medical equipment and device, encourages physicians to do initiate research, and actively cooperate closely with industry-academia research communities.
(1) Subject Health Education Animation Center website
https://www1.cgmh.org.tw/intr/intr2/c3s400/mainpage.html
(2) English website of clinical trial center
https://www1.cgmh.org.tw/intr/intr2/c3s400/e-mainpage.html
(3) Subject Health Education Animation Center youtube website
https://youtu.be/1cKj9WwrBg

Publications

CTC

1

Chen A, Chen HT, Chen HC, et al. Asymptomatic Meibomian Gland Dysfunction and Cardiovascular Disease Risk Factors in a Middle-Aged Population in Taiwan - A Cross-sectional Analysis. Sci Rep. 2017;7(1):4935.

2

Chao AS, Chang YL, Chao A, et al. Seropositivity of influenza A H1NI in mothers and infants following maternal vaccination with trivalent seasonal influenza vaccine after the 2009 pandemic. Taiwan J Obstet Gynecol. 2017;56(1):37-40.

3

Tseng JR, Chang YH, Yang LY, et al. Potential usefulness of (68)Ga-citrate PET/CT in detecting infected lower limb prostheses. EJNMMI Res. 2019;9(1):2.

4

Lin G, Yang LY, Lin YC, et al. Prognostic model based on magnetic resonance imaging, whole-tumour apparent diffusion coefficient values and HPV genotyping for stage IB-IV cervical cancer patients following chemoradiotherapy. Eur Radiol. 2019;29(2):556-565.

5

Liao CT, Lee LY, Hsueh C, et al. Tumor Depth of Invasion (Tumor > 4 cm/Depth > 10 mm and Depth > 20 mm) and Through Cortex/Skin Invasion are Both Valid Criteria for Classifying Tumors as pT4a in AJCC 2018 Oral Cavity Cancer Staging System. Ann Surg Oncol. 2019;26(11):3663-3672.

6

Liao CT, Hsieh CH, Fan WL, et al. A combined analysis of maximum standardized uptake value on FDG-PET, genetic markers, and clinicopathological risk factors in the prognostic stratification of patients with resected oral cavity squamous cell carcinoma. Eur J Nucl Med Mol Imaging. 2019.

7

Lai YC, Yeh TS, Wu RC, et al. Acute Tumor Transition Angle on Computed Tomography Predicts Chromosomal Instability Status of Primary Gastric Cancer: Radiogenomics Analysis from TCGA and Independent Validation. Cancers (Basel). 2019;11(5).

8

Lai CH, Vallikad E, Lin H, et al. Maintenance of pegylated liposomal doxorubicin/carboplatin in patients with advanced ovarian cancer: randomized study of an Asian Gynecologic Oncology Group. J Gynecol Oncol. 2019;31(1):e5.

9

Huang YT, Yang LY, Pan YB, et al. Learning Curve Analysis of Transvaginal Natural Orifice Adnexal Surgery. J Minim Invasive Gynecol. 2019.

10

Huang YH, Chen ST, Liu FH, et al. The efficacy and safety of concentrated herbal extract granules, YH1, as an add-on medication in poorly controlled type 2 diabetes: A randomized, double-blind, placebo-controlled pilot trial. PLoS One. 2019;14(8):e0221199.

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