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中國醫藥大學附設醫院臨床試驗中心Clinical Trial Center, China Medical University Hospital

  • Total Beds2,202
  • Total Doctors1,137
  • AddressNo. 2, Yude Road,North,Taichung City 404
  • ContactChung-Hsuan Yang
  • Emailctca97919@gmail.com

1. CMUH has been a trusted collaborative partner for many global pharmaceutical companies and contract research organizations (CROs). Our clinical trial partners include the world’s top 50 international pharmaceutical companies. So far, CMUH-CTC has contracted with more than 420 clinical research companies and has conducted over 1,600 clinical trials with a wide scope of therapeutic trials, including over 110 phase I studies.

2. The key focus areas of our clinical trials encompass specific cancer diseases, myocardial infarction, cellular therapy for acute myocardial infarction, multiple sclerosis, stroke, and various other diseases.

3. CMUH CTC is the very first clinical center in Taiwan to have an academic CRO (ARO) and in-house SMO to significantly reduce costs charged by commercial CROs and SMOs, while also greatly enhancing trial operations. Besides, we have established DryLab team to execute big health data analytics in generating real world evidence since 2010 with more than 2,100 papers published to date including those in topnotch journals such as JAMA, Lancet and others.

Site Introduction

In 2010, our institution established the Clinical Trial Center (CTC) to provide a comprehensive service for conducting clinical trials, which are divided into five departments with functional and mutual support for each other, including the administration team, the in-house SMO team, the training and education team, the Academic Research Organization (ARO) team, and the DryLab team. Administration team with a primary mission to provide clinical trial integrated services, management, and implementation. To speed up the initiation of the clinical trial, CTC accepts English contracts. The contracts can be submitted for review in parallel with the Research Ethics Committee and the Food and Drug Administration of the Ministry of Health and Welfare, facilitating the prompt initiation of trials. Dedicated clinical research nurses from CTC provide all necessary services required for clinical trial enrollment, assist in the coordination of trial procedures, ensure seamless operation, and offer participants the most immediate, comprehensive, and professional care. In addition, the training and education team regularly organizes domestic and international clinical trial-related activities to improve the abilities and knowledge required in trial execution. Invite experts from industry, government, and academia to provide professional training courses in person and online to continuously acquire knowledge and improve Taiwan’s competitiveness.

 

CTC set up the nation‘s first Academic Research Organization, which offers "One-stop Comprehensive Services". Compared to commercial CROs, the ARO is more efficient and cost-effective. ARO provides a wide range of services that cover clinical trial consultation, protocol design, TFDA/IRB document submission, clinical trial project management and monitoring, data management and analysis, and clinical study report writing. ARO has extensive experience in conducting clinical trials, including multinational multicenter clinical trials such as “ATACH-II” and “EXTEND” studies. Its remarkable performance has been recognized on international stages, by CNN in the United States and the European Stroke Organization. Furthermore, the outcomes of these clinical trials have been published in high-ranking SCI journals such as “The Lancet” and “The New England Journal of Medicine”.

 

The DryLab team at CTC provides clinical trial data management and related statistical analysis services, such as sample size calculation, randomization, and statistical analysis reports. We also analyze big data, such as that from the Health and Welfare Data Science Center and the Taiwan Stroke Registry, to conduct real-world studies and generate real-world evidence. This kind of study assists in the conceptualization and execution of investigator-initiated trials or serves as supplementary evidence for post-marketing studies of drug efficacy and safety. Up to now, more than 400 SCI papers related to marketed drugs have been successfully published. Some dosing recommendations and warnings that differ from the existing package insert were indicated in those studies.

 

Each team within the CTC undertakes distinct professional responsibilities to advance, supervise, and manage clinical trial affairs in the hospital. CMUH has been a trusted collaborative partner for many global pharmaceutical companies and contract research organizations (CROs). Our clinical trial partners include the world’s top 50 international pharmaceutical companies. So far, CMUH-CTC has contracted with more than 420 clinical research companies and has conducted over 1,600 clinical trials with a wide scope of therapeutic trials, including over 110 phase I studies. CMUH will enhance cooperation with the biopharmaceutical industry in clinical trials by leveraging the long-term partnership between CTC and domestic and international companies to improve the efficiency of subject recruiting and clinical trial research capacity. Our goal is to speed up the smooth launch of new drugs and medical devices and promote the health and well-being of the whole people.

Clinicl Trial Expertise

Oncology and hematology, pulmonary disease and lung cancer, gastrointestinal tract disease and hepatology, rheumatology and immunology, breast surgical oncology, urology, neurology, pediatric, cardiovascular disease, nephrology, metabolic disease, Ophthalmology, infectious disease, vaccine, cell therapy.

International 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)
Joint Commission International (JCI)
Healthcare Information and Management Systems Society (HIMSS)

GCP Inspection/audit

PMDA, TFDA, FDA

What types of clinical trial do you conduct?

Spotlights

CTC

 
 

Publications

CTC

1

Chen IW, Sun HY, Hung CC. Meta-Analysis of Efficacy and Safety of Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide Among People Living with HIV. Infect Dis Ther. 2021 Sep;10(3):1331-1346. doi: 10.1007/s40121-021-00449-z. Epub 2021 May 11. PMID: 33977505; PMCID: PMC8322367.

2

Bi XD, Lu BZ, Pan XX, Liu S, Wang JY. Adjunct therapy with probiotics for chronic urticaria in children: randomised placebo-controlled trial. Allergy Asthma Clin Immunol. 2021 Apr 17;17(1):39. doi: 10.1186/s13223-021-00544-3. PMID: 33865434; PMCID: PMC8052813.

3

Wang KL, Fang CY, Lai WT, Wang TD, Ueng KC, Wang KY, Wang JH, Shyu KG, Chiang CE. Extended-Release Carvedilol in the Treatment of Hypertension: A Double-Blind, Randomized, Placebo-Controlled Trial. Acta Cardiol Sin. 2021 Mar;37(2):186-194. doi: 10.6515/ACS.202103_37(2).20200914B. PMID: 33716461; PMCID: PMC7953114.

4

Cheng YS, Tseng PT, Wu MK, Tu YK, Wu YC, Li DJ, Chen TY, Su KP, Stubbs B, Carvalho AF, Lin PY, Matsuoka YJ, Chen YW, Sun CK, Shiue YL. Pharmacologic and hormonal treatments for menopausal sleep disturbances: A network meta-analysis of 43 randomized controlled trials and 32,271 menopausal women. Sleep Med Rev. 2021 Jun;57:101469. doi: 10.1016/j.smrv.2021.101469. Epub 2021 Mar 11. PMID: 33836486.

5

Kamkar MZ, Mahyar M, Maddah SA, Khoddam H, Modanloo M. The effect of melatonin on quality of sleep in patients with sleep disturbance admitted to post coronary care units: A randomized controlled trial. Biomedicine (Taipei). 2021 Mar 1;11(1):34-40. doi: 10.37796/2211-8039.1123. PMID: 35223393; PMCID: PMC8823467.

6

Tsai CL, Lin YW, Hsu HC, Lou ML, Lane HY, Tu CH, Ma WF. Effects of the Health-Awareness-Strengthening Lifestyle Program in a Randomized Trial of Young Adults with an At-Risk Mental State. Int J Environ Res Public Health. 2021 Feb 18;18(4):1959. doi: 10.3390/ijerph18041959.

7

Lane HY, Tu CH, Lin WC, Lin CH. Brain Activity of Benzoate, a D-Amino Acid Oxidase Inhibitor, in Patients With Mild Cognitive Impairment in a Randomized, Double-Blind, Placebo Controlled Clinical Trial. Int J Neuropsychopharmacol. 2021 May 18;24(5):392-399. doi: 10.1093/ijnp/pyab001.

8

Lo YP, Chiang SL, Lin CH, Liu HC, Chiang LC. Effects of Individualized Aerobic Exercise Training on Physical Activity and Health-Related Physical Fitness among Middle-Aged and Older Adults with Multimorbidity: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Dec 25;18(1):101. doi: 10.3390/ijerph18010101. PMID: 33375668; PMCID: PMC7794827.

9

Tseng ZF, Hsu PI, Peng NJ, Kao SS, Tsay FW, Cheng JS, Chen WC, Tsai KF, Tang SY, Chuah SK, Shie CB. Omeprazole vs famotidine for the prevention of gastroduodenal injury in high-risk users of low-dose aspirin: A randomized controlled trial. J Chin Med Assoc. 2021 Jan 1;84(1):19-24. doi: 10.1097/JCMA.0000000000000465. PMID: 33230059.

10

Wang SJ, Wang YH, Huang LC. The effect of oral low molecular weight liquid hyaluronic acid combination with glucosamine and chondroitin on knee osteoarthritis patients with mild knee pain: An 8-week randomized double-blind placebo-controlled trial. Medicine (Baltimore). 2021 Feb 5;100(5):e24252. doi: 10.1097/MD.0000000000024252. PMID: 33592868; PMCID: PMC7870173.