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長庚醫療財團法人林口臨床試驗中心Chang Gung Medical Foundation Linkou Clinical Trial Center

  • Total Beds3,488
  • Total Doctors1,769
  • AddressNo.5, Fuxing St.,Guishan,Taoyuan City 333
  • ContactHsiao-Ying Kuo, Sales Representative
  • Emailhlsweetygirl@cgmh.org.tw
  • Phone Number+886-3-3281200 ext. 7262

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

The main focus of Chang Gung Medical Foundation Clinical Trial Center includes:
  1. Optimizing the clinical trial environment to enhance execution capabilities.
  2. Promoting domestic industry development and advancing the "One Stop Window" project management model, simplifying pre-project execution processes to enhance international competitiveness in clinical trials.
  3. Establishing a framework based on the concept of "Academic Research Organization, ARO" to actively participate in domestic and foreign Biotechnology and Medicine Industry development.
  4. Implementing a management model for Clinical Research Nurses (CRNs) or Clinical Research Coordinators (CRCs).
  5. Actively implementing the system of dedicated physicians for clinical trials and talent development.

Specific measures include:
  1. Operating the clinical trial center as a "One Stop Window" project management model, streamlining pre-project evaluation processes to position Taiwan as a preferred country for executing multi-country multi-center projects. Providing observation opportunities for clinical trial centers at various locations within the system, facilitating mutual learning and strengthening the efficiency of application, contracting, and execution of cases.
  2. Enhancing the functions of industry-academia cooperation center, aiming to materialize basic medical research results and implement the "Bench to clinical" concept, serving as a gateway for collaboration with domestic and international institutions, especially focusing on assisting domestic industries in conducting clinical trials for local research and development.
  3. Constructing the ARO model in various locations within the Chang Gung System, where the cooperation model of ARO-CRO-SMO is more rational and efficient. The leading role of ARO also ensures the scientific and independent nature of clinical research, ensuring the quality of research and safeguarding the rights of research subjects, thereby reducing research risks.
  4. Leveraging the advantages of the Molecular Imaging Center to establish international standard operating procedures, setting standards for different human clinical trial imaging instruments, and collaborating with domestic companies on several biomarker developments.
  5. Promoting regenerative medicine as an emerging field by repairing and replacing damaged or aging cells and tissues through techniques such as stem cell therapy and tissue engineering. However, experience in clinical trials of regenerative medicine is lacking compared to drugs or medical devices. Therefore, this project aims to encourage domestic research in cell therapy and regenerative medicine and promote cooperation and development in related industries.
  6. Implementing the functions of the LinKou Chang Gung Proton and Radiation Therapy Center and continuing to execute six integrated projects. Clinical trials for liver cancer will conduct gender statistical analysis and differential evaluation. In addition to leading domestic multi-center clinical trials, collaboration with international partners such as MD Anderson Cancer Center will conduct two randomized phase III clinical trials that could change clinical treatment guidelines.
  7. Collaborating with Duke University to establish an international-level independent statistical validation mechanism and Phase I international network, expanding international cooperation and supporting young physicians to study abroad in collaborative medical centers.
  8. Establishing comprehensive clinical training and retention strategies, encouraging innovative physicians with industrial value to initiate clinical research independently. Implementing a system for appointing dedicated physicians for clinical trials, planning procedures for medical personnel to apply for projects abroad, and cultivating outstanding talents in the long term. Gradually incorporating the management model for CRNs or CRCs into the organization.

Clinicl Trial Expertise

Hematologic-Oncology、Nephrology、Infectious diseases、Gynecologic Oncology、cell therapy、Orthopedics、Ophthalmology、Urology、Cardiovascular Medicine、Thoracic Medicine、Dermatology、Endocrinology and Metabolism、Gastroenterology and Hepatology、Neurosurgery、Neurology、Rheumatology、General Medicine、General Surgery、Rehabilitation、Nuclear Medicine、Psychiatry

International Accreditation

AAHRPP, FERCAP, HIMSS, CAP

GCP Inspection/audit

US FDA, EMA

What types of clinical trial do you conduct?

Spotlights

CTC

Chang Gung Memorial Hospital Clinical Trial Center provides "One Stop Window" project management, improves execution efficiency, strengthens industry-university cooperation, implements the concept of "Bench to clinical", and constructs an academic research organization "Academic Research Organization, ARO" to implement in It is more reasonable and efficient for all campuses in the Chang Gung Memorial System to participate in the cooperation model ARO-CRO-SMO, which ensures the research quality of the research team, protects the rights and interests of research subjects, and reduces the risks of research.
Integrated service performance of industry-university-clinical trials: Collaborating with NaviFUS Corp. to develop the clinical application of high-end medical materials " Non-invasive Focused Ultrasound Brain Drug Delivery System ", which is a popular technology in clinical practice. Currently, this This technology development is implemented by three major teams: Canada/Israel, France, and Taiwan. Among them, Taiwan's technology has the greatest development potential. This technology transfer was carried out independently by NaviFUS Corp. in our hospital for Phase I clinical trials. This research won the American Edison Award in April 2022.

Publications

CTC

1

Chen, P. Y., Su, I. C., Shih, C. Y., Liu, Y. C., Su, Y. K., Wei, L., Luh, H. T., Huang, H. C., Tsai, P. S., Fan, Y. C., & Chiu, H. Y. (2023). Effects of Neurofeedback on Cognitive Function, Productive Activity, and Quality of Life in Patients With Traumatic Brain Injury: A Randomized Controlled Trial. Neurorehabilitation and neural repair, 37(5), 277–287. https://doi.org/10.1177/15459683231170539

2

Huang, W. K., Hsu, H. C., Yang, T. S., Lu, C. W., Pan, Y. R., Wu, C. E., Chung, W. H., Hung, S. I., & Yeh, C. N. (2023). Zinc supplementation decreased incidence of grade ≥2 hand-foot skin reaction induced by regorafenib: A phase II randomized clinical trial. European journal of cancer (Oxford, England : 1990), 195, 113286. https://doi.org/10.1016/j.ejca.2023.113286

3

Shen, W. C., Hou, M. M., Huang, T. L., Wang, C. H., Huang, Y. M., Chen, J. S., & Chen, M. L. (2023). Transdermal buprenorphine improves overall quality of life and symptom severity in cancer patients with pain. Journal of clinical nursing, 32(3-4), 539–547. https://doi.org/10.1111/jocn.16303

4

Huang, T. L., Huang, Y. M., Hou, M. M., Lu, C. H., Chao, T. Y., Chiu, T. J., Chang, Y. S., Lin, S. H., Lin, C. H., Chen, Y. H., Wang, C. H., Chen, J. S., & Shen, W. C. (2023). Safety and effectiveness of transdermal buprenorphine in cancer pain: An observational study in Taiwan (SOOTHE). Asia-Pacific journal of clinical oncology, 19(2), e45–e53. https://doi.org/10.1111/ajco.13772

5

Wang, C. H., Chen, W. S., Liu, M. H., Lee, C. Y., Wang, M. Y., Liang, C. Y., Chu, C. M., Wu, H. P., & Chen, W. H. (2022). Stress Hyperphenylalaninemia Is Associated With Mortality in Cardiac ICU: Clinical Factors, Genetic Variants, and Pteridines. Critical care medicine, 50(11), 1577–1587. https://doi.org/10.1097/CCM.0000000000005640

6

Wei, Y. C., Chen, C. K., Lin, C., Chen, P. Y., Hsu, P. C., Lin, C. P., Shyu, Y. C., & Huang, W. Y. (2022). Normative Data of Mini-Mental State Examination, Montreal Cognitive Assessment, and Alzheimer's Disease Assessment Scale-Cognitive Subscale of Community-Dwelling Older Adults in Taiwan. Dementia and geriatric cognitive disorders, 51(4), 365–376. https://doi.org/10.1159/000525615

7

Yang, J. Y., Chen, C. C., Chang, S. C., Yeh, J. T., Huang, H. F., Lin, H. C., Lin, S. H., Lin, Y. H., Wei, L. G., Liu, T. J., Hung, S. Y., Yang, H. M., Chang, H. H., Wang, C. H., Tzeng, Y. S., Huang, C. H., Chou, C. Y., Lin, Y. S., Yang, S. Y., Chen, H. M., … Dai, N. T. (2022). ENERGI-F703 gel, as a new topical treatment for diabetic foot and leg ulcers: A multicenter, randomized, double-blind, phase II trial. EClinicalMedicine, 51, 101497. https://doi.org/10.1016/j.eclinm.2022.101497

8

Chen, J. Y., Hsieh, S. M., Hwang, S. J., Liu, C. S., Li, X., Fournier, M., Yeh, T. Y., Yin, J. K., & Samson, S. I. (2022). Immunogenicity and safety of high-dose quadrivalent influenza vaccine in older adults in Taiwan: A phase III, randomized, multi-center study. Vaccine, 40(45), 6450–6454. https://doi.org/10.1016/j.vaccine.2022.09.078

9

Lee, C. T., Lee, C. C., Wu, M. J., Chiu, Y. W., Leu, J. G., Wu, M. S., Peng, Y. S., Wu, M. S., & Tarng, D. C. (2022). Long-term safety and efficacy of ferric citrate in phosphate-lowering and iron-repletion effects among patients with on hemodialysis: A multicenter, open-label, Phase IV trial. PloS one, 17(3), e0264727. https://doi.org/10.1371/journal.pone.0264727

10

Hsieh, M. J., Chen, N. H., Cheng, S. L., Tao, C. W., Wei, Y. F., Wu, Y. K., Chan, M. C., Liu, S. F., Hsu, W. H., Yang, T. M., Lin, M. S., Liu, C. L., Kuo, P. H., & Tsai, Y. H. (2022). Comparing Clinical Outcomes of Tiotropium/Olodaterol, Umeclidinium/Vilanterol, and Indacaterol/Glycopyrronium Fixed-Dose Combination Therapy in Patients with Chronic Obstructive Pulmonary Disease in Taiwan: A Multicenter Cohort Study. International journal of chronic obstructive pulmonary disease, 17, 967–976. https://doi.org/10.2147/COPD.S353799