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

  • Total Beds2,076
  • Total Doctors884
  • AddressNo. 2, Yude Road,North,Taichung City 404
  • ContactChung-Hsuan Yang
  • Emaila97919@mail.cmuh.org.tw
Link to Hospital Link to Clinical Trial Center

1. Clinical Trial Center at China Medical University Hospital has been in collaboration with 294 international, domestic pharmaceutical and biotech companies as well as national research institutes including top 25 companies in the world with a wide scope of therapeutic trials including those applying stem cells for treating stroke, acute myocardial infarction, selected types of cancers and others.

2. Clinical Trial Center at China Medical University Hospital is the very first clinical center in Taiwan to have an academic CRO (ARO) and in-house SMO to substantially reduce the costs charged by commercial CROs and SMO and greatly improve trial operation.

3. Clinical Trial Center at China Medical University Hospital has established a team to execute big health data analytics in generating real world evidence since 2010 with more than 1,400 papers published to date including those in topnotch journals such as JAMA, Lancet and others.

Site Introduction

Funded by the Ministry of Health and Welfare in 2010, this center has been holding the principle with the priorities placed on the sponsors and PIs to provide single-window, streamlining full services with high-efficiency safest execution of clinical trials at significantly lower costs than the traditional clinical trial centers with the priority set to assist sponsors and PIs to advance their intellectual properties onto the market in a timely manner.

The Center is built upon 5 sections as detailed below:

  1. Administrative and Budgetary Management:This Section is responsible for contract signing and the following management roles: budgetary control, equipment oversight, personnel, sample processing and storage as well as website maintenance.
  2. In-house SMO: This team with special training in conducting clinical trial procedures under the supervisions of sponsors and PIs also undertake the tasks in processing IRB review, tracking of trial processes, adherence to trial protocols, acceleration of enrollment rates and assurance of the safety of trial subjects.
  3. Academic CRO (ARO):ARO is the first in Taiwan established by our center which carries all duties conducted by commercial CRO. Its responsibilities include review submission of new trials, follow and management of trial progression, conduction of trial monitoring, trial audit including trial data management and statistical analysis of trial results as well as preparation of final trial reports. With this ARO, the trial efficiency has been substantially improved with much lower costs than those charged by commercial CROs.
  4. Quality Assurance and Personnel Training and Education: Manage and monitoring SOPs with periodic internal auditing as well as conducting training courses.　This section is also responsible for sponsoring national and international conferences relevant to trials and cultivation of clinical trial personnel in different disciplines.
  5. Big Health Data Analytics:A team of 6 full-time biostatistician has been assembled since 2010 for big health data analytics with establishment of real world evidence as one of the primary objective. This team has assisted in publishing more than 1,400 papers with 312 highly relevant to the beneficial or adverse actions of selected drugs and medical devices that have not been included in package insert. This team has also been responsible for the management and quality maintenance of Taiwan Stroke Registry.

Clinicl Trial Expertise

This center has had broad collaboration with a large number of international and domestic pharmaceutical and biotech companies as well as research institutions in other countries such as NIH in the US to carry out a large number of clinical trials covering the whole spectrum of diseases and healthcare issues.

International Accreditation

GCP Inspection/audit

PMDA, TFDA

What types of clinical trial do you conduct?

Spotlights

CTC

  1. Since 2010, the Clinical Trial Center (CTC) at China Medical University Hospital has been in collaboration with 294 international and domestic pharmaceutical and biotech companies as well as research institutions and CROs including the top 25 pharmaceutical companies in the world.
  2. From 2017 to date, CTC has contributed in advancing 59 new drugs or medical devices to the market.
  3. CTC joined EXTEND, a multincational clinical trial with results published in New England Journal of Medicine (IF: 79.258) and Lancet (IF: 53.254)。
  4. CTC joined ATACH II, a multincational clinical trial sponsored by NIH in the US with results published in New England Journal of Medicine (IF: 79.258) and JAMA Neurology (IF: 12.321).
  5. ATACH results showing that lowering blood pressure in patients with intracranial hemorrhage were not effective have been cited by the Ministry of Economic Affairs in its 2019 edition of the White Book.
  6. Society for Clinical Research Sites (SCRS) is the largest association of clinical trial centers with more than 9,500 centers from 47 countries joining including topnotch clinical trial centers at Harvard, Stanford, Cambridge, Oxford, Duke, Mayo Clinic, Cornell-Columbia, MD Anderson and others。The PI of this center (Prof. Chung Y. Hsu) has been appointed as SCRS Taiwan Ambassador and giving the privilege to hold SCRS Taiwan Ambassador Symposium every year starting 2019.
  7. International Clinical Trial Center Newwork (ICN) has been established by topnotch universities including Harvard, Cambridge and other topnotch universities. This center is the only member from Taiwan to join ICN. The Director of this Center (Prof. Chung Y. Hsu) has been invited to deliver a lecture entitled “Beyond Multicenter Clinical Trial Results: Application of Big Health Databases to Establish Real World Evidence.” in the 2019 ICN Symposium.
  8. ARO (Academic CRO) and In-House SMO, first established at our Center in Taiwan has been effectively operation clinical trials with one single communication window, one-step and full services to facilitate the execution of clinical trials.
  9. CTC has established Taiwan Stroke Registry with more than 60 stroke centers joining and has more than 150,000 stroke patients registered.
  10. China Medical University was funded with traditional Chinese medicine (TCM) as the main thrust. This center has taken the advantages of the unique strengths of TCM to establish scientific basis of selected TCMs.

Publications

CTC

1

Ma H, Campbell BCV, Parsons MW, Churilov L, Levi CR, Hsu C, Kleinig TJ, Wijeratne T, Curtze S, Dewey HM, Miteff F, Tsai CH, Lee JT, Phan TG, Mahant N, Sun MC, Krause M, Sturm J, Grimley R, Chen CH, Hu CJ, Wong AA, Field D, Sun Y, Barber PA, Sabet A, Jannes J, Jeng JS, Clissold B, Markus R, Lin CH, Lien LM, Bladin CF, Christensen S, Yassi N, Sharma G, Bivard A, Desmond PM, Yan B, Mitchell PJ, Thijs V, Carey L, Meretoja A, Davis SM, Donnan GA; EXTEND Investigators. Thrombolysis Guided by Perfusion Imaging up to 9 Hours after Onset of Stroke. N Engl J Med. 2019 May 9;380(19):1795-1803. doi: 10.1056/NEJMoa1813046.

2

Campbell BCV, Ma H, Ringleb PA, Parsons MW, Churilov L, Bendszus M, Levi CR, Hsu C, Kleinig TJ, Fatar M, Leys D, Molina C, Wijeratne T, Curtze S, Dewey HM, Barber PA, Butcher KS, De Silva DA, Bladin CF, Yassi N, Pfaff JAR, Sharma G, Bivard A, Desmond PM, Schwab S, Schellinger PD, Yan B, Mitchell PJ, Serena J, Toni D, Thijs V, Hacke W, Davis SM, Donnan GA; EXTEND, ECASS-4, and EPITHET Investigators. Extending thrombolysis to 4•5-9 h and wake-up stroke using perfusion imaging: a systematic review and meta-analysis of individual patient data. Lancet. 2019 Jul 13;394(10193):139-147. doi:10.1016/S0140-6736(19)31053-0. Epub 2019 May 22.

3

Ton G, Lee LW, Ng HP, Liao HY, Chen YH, Tu CH, Tseng CH, Ho WC, Lee YC. Efficacy of laser acupuncture for patients with chronic Bell's palsy: A study protocol for a randomized, double-blind, sham-controlled pilot trial. Medicine (Baltimore). 2019 Apr;98(15):e15120. doi: 10.1097/MD.0000000000015120.

4

Shih YS, Tsai CH, Li TC, Yu CJ, Chou JW, Feng CL, Wang KT, Lai HC, Hsieh CL. Effect of wu chu yu tang on gastroesophageal reflux disease: Randomized, double-blind, placebo-controlled trial. Phytomedicine. 2019 Mar 15;56:118-125. doi: 10.1016/j.phymed.2018.09.185. Epub 2018 Sep 18.

5

Lee CC, Chang HH, Lu MY, Yang YL, Chou SW, Lin DT, Jou ST, Yao M, Li CC, Yeh SP, Chen MH, Gau JP, Li SS, Wang PN, Liu YC, Wang TF, Tan TD, Lee MY, Yu MS, Wang CC, Lin SC, Chen YC, Su YC, Su KY, Lin KH. The incidence and risk factors of hepatic veno-occlusive disease after hematopoietic stem cell transplantation in Taiwan. Ann Hematol. 2019 Mar;98(3):745-752. doi: 10.1007/s00277-019-03604-2. Epub 2019 Jan 21.

6

Lee CY, Tai CJ, Tsai YF, Kuan YH, Lee CH, Huang KH. Prescribing Trend of Antirheumatic Drugs in Taiwan and Risk of Cardiovascular Disease in Patients with Rheumatoid Arthritis: A Nationwide Cohort Study. Biomed Res Int. 2019 Feb 20;2019:7987529. doi: 10.1155/2019/7987529. eCollection 2019. PubMed PMID: 30915358;

7

Yu ML, Hung CH, Huang YH, Peng CY, Lin CY, Cheng PN, Chien RN, Hsu SJ, Liu CH, Huang CF, Su CW, Huang JF, Liu CJ, Kao JH, Chuang WL, Chen PJ, Chen DS. Efficacy and safety of 12 weeks of daclatasvir, asunaprevir plus ribavirin for HCV genotype-1b infection without NS5A resistance-associated substitutions. J Formos Med Assoc. 2019 Feb;118(2):556-564. doi: 10.1016/j.jfma.2018.11.007. Epub 2018 Dec 5.

8

Yuan J, Mo B, Ma Z, Lv Y, Cheng SL, Yang Y, Tong Z, Wu R, Sun S, Cao Z, Wu J, Zhu D, Chang L, Zhang Y; Investigator Group of the Phase 3 Study on Oral Nemonoxacin. Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial. J Microbiol Immunol Infect. 2019 Feb;52(1):35-44. doi: 10.1016/j.jmii.2017.07.011. Epub 2017 Aug 2.

9

Nicoli F, Orfaniotis G, Ciudad P, Maruccia M, Lazzeri D, Costabile L, Li K, Zhang YX, Cervelli V, Balzani A. Correction of cicatricial ectropion using non-ablative fractional laser resurfacing. Lasers Med Sci. 2019 Feb;34(1):79-84. doi: 10.1007/s10103-018-2601-y. Epub 2018 Jul 28.

10

Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. doi:10.1016/S0140-6736(18)32984-2. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228.

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