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臺北醫學大學聯合臨床試驗中心Joint Clinical Research Center, Taipei Medical University

  • Total Beds2,648
  • Total Doctors922
  • Address3F., No. 301, Yuantong Rd.,Zhonghe,New Taipei City 235
  • ContactHui-Hsin Cheng (Deputy Director)
  • Emailleila148@tmu.edu.tw
  • Phone Number+886-2-6620-2589 #15315
Link to Hospital Link to Clinical Trial Center

1. Single administration system to operate IRB, contracting and trial management of multi-center clinical trial.

2. Provide academic clinical trial organization (ARO) services to assist the biomedical industry with a complete biomedical acceleration system from pharmaceutical development, clinical trials to product launch.

3. TMU Healthcare System has been accredited by AAHRPP Full Accreditation third and followed ICH-GCP guideline.

Site Introduction

To manage clinical trials in 3 affiliated hospitals, TMU launched Joint Clinical Research Center (JCRC) and successfully introduced trials jointly accepted by the 3 affiliated hospitals.

Therefore, JCRC as one of departments of the Office of Human Research (OHR) plays the most important role in clinical research. We used Single-Window system to take all the clinical trial business in which the three affiliated hospitals can conducting trial simultaneously. OHR also incorporated JIRB for the ethical review service. This JIRB can be accepted by 3 hospitals at the same time through a single review process, which reduce many unnecessary times to process redundant application procedure. In addition, TMU JIRB is MOHW accredited central IRB (cIRB) review board. In order to ensure the quality of the clinical trials, we have a Data Safety Management Session (DSMS) to be responsible for data audit and safety monitoring. To conducting clinical research effortlessly, we established Joint Biobank (JBB) to collect clinical specimens from 3 hospitals. These specimens provide resources for clinical research. JBB also deliver high-end precision diagnosis for clinical services.

Taipei Medical University Healthcare system manage the international and national collaboration by providing AI Medicare with big data analysis for the drug development, cell therapy, and precision medicine. We also operate the medical professional as one team to include our scientists, clinical research centers, and clinical trial professionals for the conducting of international clinical trials.

Clinicl Trial Expertise

Oncology、Thoracis Medicine、Neurology、Infectious Disease、Renal Urology、AI in Medicine、Cell Therapy and Regenerative Medicine、Medical Devices、Metabolism、Rheumatology、Rare Disease、Health Volunteer(phase I)、dermatology、Cardiovascular diseases

International Accreditation

AAHRPP, FERCAP, JCI, TAF-CNLA, CAP-LAP

GCP Inspection/audit

US FDA, PMDA and Malaysia FDA inspections with no major finding.

What types of clinical trial do you conduct?

Spotlights

CTC

Taipei Medical University established a comprehensive accelerator system for the incubation, clinical trial, industrialization and commercialization of any biomedical products. This system provides a foundation for the successful business development of the national and international biomedical researches.
(1) TMU has linked up with 11 alliance hospitals in Taiwan, and actively cooperates with the alliance hospitals to implement clinical trials commissioned by manufacturers and initiated by physicians themselves. (2) Adhere to the single window system to serve domestic and foreign manufacturers, and proactively visit various biomedical parks. (3) Through the ARO service model, we will fully guide the domestic new biomedical industry to develop the research and development capacity of new drugs and new medical materials. (4) Through the Office of Data Science of TMU, we continue to promote structured electronic medical records in hospitals affiliated to the Taipei Medical University system to build a complete real data database.

Publications

CTC

1

Nunn AJ, Phillips PPJ, Meredith SK, Chiang CY, Conradie F, Dalai D, van Deun A, Dat PT, Lan N, Master I, Mebrahtu T, Meressa D, Moodliar R, Ngubane N, Sanders K, Squire SB, Torrea G, Tsogt B, Rusen ID; STREAM Study Collaborators. A Trial of a Shorter Regimen for Rifampin-Resistant Tuberculosis. N Engl J Med. 2019 Mar 28;380(13):1201-1213.

2

Chen IH, Yeh TP, Yeh YC, Chi MJ, Chen MW, Chou KR, Lien YY, Yuan CF. Effects of Acupressure on Sleep Quality and Psychological Distress in Nursing Home Residents: A Randomized Controlled Trial. J Am Med Dir Assoc. 2019 Feb 20. pii: S1525-8610(19)30005-2.

3

Chen YC, Lin FY, Lin YW, Cheng SM, Lin RH, Chuang CL, Sheu JS, Chen SM, Chang CC, Tsai CS. DAPT Plus Cilostazol is Better Than Traditional DAPT or Aspirin Plus Ticagrelor as Elective PCI for Intermediate-to-Highly Complex Cases: Prospective, Randomized, PRU-Based Study in Taiwan. Am J Cardiovasc Drugs. 2019 Feb;19(1):75-86.

4

Chan PT, Chang WC, Chiu HL, Kao CC, Liu D, Chu H, Chou KR. Effect of interactive cognitive-motor training on eye-hand coordination and cognitive function in older adults. BMC Geriatr. 2019 Jan 28;19(1):27.

5

Yang HL, Chu H, Kao CC, Chiu HL, Tseng IJ, Tseng P and Chou KR. Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Age and ageing. 2019. [Epub ahead of print]

6

Chang JP, Chang SS, Yang HT, Chen HT, Chien YC, Yang B, Su H and Su KP. Omega-3 polyunsaturated fatty acids in cardiovascular diseases comorbid major depressive disorder - Results from a randomized controlled trial. Brain, behavior, and immunity. 2019. [Epub ahead of print]

7

Satyanarayanan SK, Chien YC, Chang JP, Huang SY, Guu TW, Su H and Su KP. Melatonergic agonist regulates circadian clock genes and peripheral inflammatory and neuroplasticity markers in patients with depression and anxiety. Brain Behav Immun. 2019.doi: 10.1016/j.bbi.2019.03.003.

8

Yang TH, Chen YC, Ou TH and Chien YW. Dietary supplement of tomato can accelerate urinary aMT6s level and improve sleep quality in obese postmenopausal women. Clin Nutr. 2019.

9

Wu JM, Kuo TC, Chen HA, Wu CH, Lai SR, Yang CY, Hsu SY, Ho TW, Liao WC and Tien YW (2019) Randomized trial of oral versus enteral feeding for patients with postoperative pancreatic fistula after pancreatoduodenectomy. Br J Surg 106:190-198.

10

Tsai JC, Lin YK, Huang YJ, Loh EW, Wen HY, Wang CH, Tsai YT, Hsieh WS and Tam KW. Antiseptic effect of conventional povidone-iodine scrub, chlorhexidine scrub, and waterless hand rub in a surgical room: a randomized controlled trial-ADDENDUM. Infect Control Hosp Epidemiol 2019, 40:267.

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