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TAIWAN SPOTLIGHT

Here you can find information of Taiwan clinical trial environment including clear and expedited review process, c-IRB system, international accreditations and real world databases in Taiwan.

CLINICAL TRIAL CENTERS

There are many excellent clinical trial centers in Taiwan. They have internationally acclaimed infrastructure, outstanding clinical trial professionals and conduct high quality, GCP-compliant clinical trials.

c-IRB

Collaborative IRB (c-IRB) is a synchronized more efficient ethic review process that aims to control review timeline and simplify the application process for multi-center clinical trials.

TAIWAN CLINICAL TRIALS CONSORTIUM

Taiwan Clinical Trials Consortium (TCTC) brings together 12 disease-specific clinical trial consortia, involving more than 280 experienced clinical trial members and PIs.

Taiwan Principal Investigator Database

TPIDB is a database of all clinical trials approved and conducted in Taiwan. Including information about PIs and clinical trial sites.

Statistical

Qualified

Clinical Trial Sites

0

JCI

Gold Seal Of Approval® Organizations

0

FERCAP

Recognized IRBs/ECs

0

AAHRPP

Fully Accreditation IRBs/ECs

0

0

days average (2021)

Expedited review process

Clinical Trial Notification (CTN)

0%

reviewed within 20 days

Synchronized Ethics Review

Collaborative IRB (c-IRB)

Total Approved

Clinical Trials

in taiwan

2008

2021

  • trials

    0

  • MRCT

    0%

Clinical Trial Centers

All listed clinical trial centers are recognized as teaching hospitals or medical centers by the Taiwan Ministry of Health and Welfare (MOHW). They have well-organized infrastructure and conduct high quality, GCP-compliant clinical trials.

  • Chang Gung Medical Foundation Linkou Clinical Trial Center

    • Taoyuan City

      Location

    • 3,488

      beds

    • 1,769

      doctors/PIs

    • Promotion of early phase clinical trials.
    • Promote the development of domestic and international biotechnology.
    • Promote education of clinical trial training.

  • Clinical Trial Center, China Medical University Hospital

    • Taichung City

      Location

    • 2,202

      beds

    • 1,137

      doctors/PIs

    • 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.
    • 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.
    • 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.

  • KMUH Clinical Trial Center

    • Kaohsiung City

      Location

    • 1,720

      beds

    • 834

      doctors/PIs

    • Full accredited from the AAHRPP (2018.12, 2022.03) and JCI (2023.03).
    • The first hospital to establish a spinal muscular atrophy treatment team in Taiwan.
    • First site that had been approved by MOHW for face transplant clinical trial in Taiwan.

  • National Cheng-Kung University Hospital Clinical Trial Center

    • Tainan City

      Location

    • 1,342

      beds

    • 899

      doctors/PIs

    • Having Early Phase unit equipment and much experience in early phase trials , including 506 Phase I-II early phase trials.
    • Have a team of Clinical Research Nurse and complete grade classification.
    • Provide one-stop project matching and management service.

  • National Taiwan University Hospital Clinical Trial Center

    • Taipei City

      Location

    • 2,106

      beds

    • 570

      doctors/PIs

    • From 2023 to 2024, our team had three H. pylori-related studies published in the prestigious international journal "Lancet Gastroenterology and Hepatology," and all were selected for the respective issue's cover. 1. Utilizing shotgun metagenomics sequencing, we found that the resistome transiently increases two weeks after second-line H. pylori eradication but returns to pre-treatment levels by the eighth week and one year. (Published in March 2023) 2. Molecular testing-guided therapy for H. pylori infection in both first-line and third-line therapy showed non-inferior efficacy compared to traditional susceptibility guided therapy guided. The results support the use of molecular testing-guided therapy for precision treatment of H. pylori infection. (Published in July 2023) 3. Meta-analysis analysis revealed an increase trend in primary resistance rates of clarithromycin, levofloxacin, and metronidazole for H. pylori in various Asia-Pacific countries, while the resistance rates for amoxicillin and tetracycline remained stable. Significant heterogeneity in antibiotic resistance among Asian countries was observed. (Published in January 2024)
    • The Taiwan Breast Cancer Consortium (TBCC) conducted a collaborative study across multiple hospitals in Taiwan comparing the efficacy of whole-brain radiotherapy (WBRT) alone versus WBRT preceded by combination therapy with Bevacizumab, Etoposide, and Cisplatin in untreated breast cancer patients with brain metastases. The paper has been published in JAMA Oncology, with Dr. Yen-Shen Lu listed as the corresponding author. Whole-Brain Radiotherapy Alone vs Preceded by Bevacizumab, Etoposide, and Cisplatin for Untreated Brain Metastases From Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. Published online December 21, 2023. doi:10.1001/jamaoncol.2023.5456
    • Immune cell therapy, as a new field of cancer treatment, has been rapidly developing worldwide over the past decade. The Hematology Department at National Taiwan University Hospital (NTUH) has accumulated years of experience in cell therapy and early-phase clinical trials of drugs. They have established a clinical trial team for immune cell therapy and built a cell processing laboratory and clinical cell therapy center that meet clinical standards. They have actively engaged with many domestic biotech companies focused on developing cell therapies, from collaborating on preclinical product development to discussing details of early-phase clinical trial designs and execution, to conducting formal clinical trials. They aim to combine the clinical and industrial sectors to bring products to the clinical field to benefit patients. Both gene-unmanipulated adoptive cell therapy (ACT) and gene-manipulated chimeric antigen receptor T-cell therapy (CAR-T) are the research targets of NTUH's immune cell therapy clinical trial team. The team will focus on the further clinical development of immune cell therapy in NTUH and Taiwan. The main directions include the following:A. Collaborative research and development of cell processes before clinical trials. B. Implementation of clinical trials for cell therapy. C. Establishment of Clinical Field for Cell Therapy. Since 2020, our project has embarked on a collaborative journey with both domestic and international biotech industries, initiating with preclinical research and progressively expanding into multinational clinical trials of CAR-T cell therapy, encompassing Phase I/II and Phase III studies. Over the past four years, we have conducted a total of 141 CAR-T clinical trials in collaboration with five biotech and pharmaceutical companies worldwide, comprising 131 preclinical studies, 8 Phase I/II trials, and 2 Phase III trials. Notably, two CAR-T drugs developed in partnership with domestic biotech enterprises are preparing to commence Phase I clinical trials in the third quarter of this year. Furthermore, leveraging Taiwan's pioneering role in cellular therapy research, along with our robust infrastructure and environment, National Taiwan University Hospital has been distinguished as the first medical center in Taiwan to be certified by Novartis as a CAR-T center, offering the commercially available Kymriah for standard treatment. Since 2022, we have successfully completed 20 treatments, leading in the CAR-T cell therapy field in Taiwan.

  • Joint Clinical Research Center, Taipei Medical University

    • New Taipei City

      Location

    • 2,648

      beds

    • 922

      doctors/PIs

    • Single administration system to operate IRB, contracting and trial management of multi-center clinical trial.
    • 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.
    • TMU Healthcare System has been accredited by AAHRPP Full Accreditation third and followed ICH-GCP guideline.

  • Taipei Veterans General Hospital General Clinical Research Center

    • Taipei City

      Location

    • 3,175

      beds

    • 1,392

      doctors/PIs

    • The headquarter of cardiovascular metabolic consortium in Taiwan
    • A hub of rare disease trial in Taiwan
    • A stem cell research headquarter in Taiwan

  • Cathay General Hospital Center of Clinical Trial and Research

    • Taipei City

      Location

    • 839

      beds

    • 365

      doctors/PIs

    • Professional medical research group with good clinical trial experiment.
    • Provide environment and qualified equipment for clinical trial research.
    • Medical Center located in the center of Taipei with convenient transportation.

  • Chi Mei Hospital Clinical Trial Center

    • Tainan City

      Location

    • 1,288

      beds

    • 677

      doctors/PIs

  • Kaohsiung Chang Gung Memorial Hospital Clinical Trial Center

    • Kaohsiung City

      Location

    • 2,691

      beds

    • 586

      doctors/PIs

    • Reinforce management of clinical trial and simplify pre-implementation process
    • Establish comprehensive clinical trial training programs and encourage investigator to conduct investigator-initiating clinical researches with high industrial value and innovation
    • Implement subject protection programs and improve potential subject’s awareness of clinical trial.

  • Changhua Christian Medical Foundation Changhua Christian Hospital Clinical Trial Center

    • Changhua County

      Location

    • 1,648

      beds

    • 654

      doctors/PIs

    • Conduct about 150 new drug clinical trials every year
    • Changhua Christian healthcare system includes 6 district hospitals and 1 cooperation hospital , set up an excellent referral system
    • Full Accreditation Awarded by AAHRPP

  • Chung Shan Medical University Hospital-New Drug, New Medical Device, New Medical Technology Clinical Trial Management Center

    • Taichung City

      Location

    • 1,134

      beds

    • 483

      doctors/PIs

    • Provide one stop shop service window
    • Online contract reviewing system.
    • Regularly hold clinical trial education training courses

  • E-Da Hospital Western Medicine Clinical Center

    • Kaohsiung City

      Location

    • 1,066

      beds

    • 417

      doctors/PIs

  • Taoyuan General Hospital, Ministry and Welfare

    • Taoyuan City

      Location

    • 1,052

      beds

    • 213

      doctors/PIs

    • A Focal (Flagship) Hospital dedicated in clinical research development.
    • In the COVID-19 pandemic, TYGH served as the gateway hospital for tourists and citizens entering Taiwan and conducted multiple clinical research related to COVID-19. Such research include, but not limited to: New drug development, NRICM0101 clinical trial, Quinine IIT, COVID-19 rapid antigen test…etc.
    • Collaborating with National Health Research Institute Taiwan Cooperative Oncology Group to conduct cancer clinical research

  • MacKay Memorial Hospital Clinical trials office

    • Taipei City

      Location

    • 2,100

      beds

    • 1,246

      doctors/PIs

    • one-stop service
    • Clinical Pharmacology Unit (CPU)- In cooperation with Protech Pharmaservices Corporation, the unit at MMH Tam-Sui branch in June 2012.
    • The hospital has a large number of patients and many types of diseases.

  • Shin Kong Wu Ho Su Memorial Hospital Clinical Trial Center

    • Taipei City

      Location

    • 817

      beds

    • 461

      doctors/PIs

    • Help SPONSOR and CROS to find and support the feasibility of the PIs ability about the ongoing trials
    • We have office of clinical trial center for the data reservoir of the SPONSORS/CROS/SCs, as well as the site monitor place
    • We have clinical trial ward for the patient who needs to receive trial with admission

  • Taipei City Hospital Center for Clinical Trials

    • Taipei City

      Location

    • 3,078

      beds

    • 850

      doctors/PIs

    • The merger of ten Taipei municipal hospitals into one unit has made the Taipei City Hospital a large healthcare institutein Northern Taiwan. The purpose of this merger was not only to improve hospital-and community- based healthcare, but also to rebuild Taipei City’s entire public healthcare system. The theme of this reform was the creation of a “Wholistic Care System”.
    • Taipei City Hospital has a total of 7 branches, which are located in various administrative districts of Taipei City. The supply of hospital beds is sufficient, and the resources of each institution are shared among seven branches and thus the research efficacy could be enhanced.
    • Our hospital is committed to Home care, Palliative care, Long-term care, and Integrated dementia care, and so is capable of developing clinical trials of related medical devices.

  • Taichung Veterans General Hospital Clinical Trials Center

    • Taichung City

      Location

    • 1,622

      beds

    • 934

      doctors/PIs

    • Smart Healthcare and Decentralized Trial System
    • Development in Cellular Therapy and Innovative Medical Technology
    • Comprehensive Academic Support System from Research Development to Implementation

  • Tri-Service General Hospital General Clinical Research Center

    • Taipei City

      Location

    • 1,800

      beds

    • 800

      doctors/PIs

    • Contribute to perform the phase I clinical trials
    • Full-time professional research nurses、specialty contract management and equipment maintenance calibration manager.
    • Independent & exclusive ward spaces、access control、yellow-light environment in the executive areas、freezers’ temperature by central monitor、primary-secondary clocks corrected by GPS.

  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Clinical Trial Center

    • Hualien County

      Location

    • 970

      beds

    • 418

      doctors/PIs

    • Patient safety first in clinical trial.
    • Full time research nurse for clinical trial execution and services for CRO.
    • One-stop service for trial sponsor, CRO and PI and high efficient process of contract and ethic review.

  • Clinical Trial Center of Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    • New Taipei City

      Location

    • 1,013

      beds

    • 385

      doctors/PIs

    • The goal of CTC is focus on the quality of clinical trials and pursuit of excellence. About half of completed clinical trials are global pharmaceutical clinical trials
    • The hospital has an independent building of Division of Psychiatry, and because it is General Hospital, which can provide clinical trial participants with other support.

  • Kaohsiung Veterans General Hospital Division of Clinical Trials

    • Kaohsiung City

      Location

    • 1,274

      beds

    • 701

      doctors/PIs

    • Provide high-quality, warm, and reliable healthcare.
    • Establish a patient safety-oriented clinical trial environment which could integrate prediction, prevention, personalization, and participation.
    • Develop science and technology to benefit both research and clinical medicine.

  • Far Eastern Memorial Hospital Clinical Trial Center

    • New Taipei City

      Location

    • 1,329

      beds

    • 616

      doctors/PIs

    • The institution and research team have ample experience in conducting clinical trials for cell therapy.
    • They possess rigorous procedures for executing clinical trials, ensuring the rights and safety of participants.
    • They promote early-stage clinical trials and continuing education in clinical trial practices.
Chang Gung Medical Foundation Linkou Clinical Trial Center

  • Taoyuan City

    Location

  • 3,488

    beds

  • 1,769

    doctors/PIs

  • Promotion of early phase clinical trials.
  • Promote the development of domestic and international biotechnology.
  • Promote education of clinical trial training.

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