TW EN

scroll

Go Top

臺大醫院臨床試驗中心National Taiwan University Hospital Clinical Trial Center

  • Total Beds2,600
  • Total Doctors1,008
  • Address7 Chung Shan S. Rd.,Zhongzheng,Taipei City 100
  • ContactSin-Jie Lin
  • Emaillinsinjie@ntuh.gov.tw

1. Liver cancer is one of the major malignancies in Taiwan, in terms of prevalence and mortality rates. Based on the efforts of our experts and research team, we have cooperated with many global and local pharmaceutical companies to develop various investigator-initiated clinical trials or to lead many sponsor-initiated clinical trials. The efforts also facilitate the recent approval of cabozantinib and ramucirumab by US-FDA in advanced HCC. These accomplishments make our institute one of the most competitive center in the field of new cancer drug development.

2. The largest oncology phase I trial center in Asia. Have completed many phase I trials of immunotherapy (PDR001 + MBG453 preliminary results presented at ESMO 2019), targeted therapy (DS8201a preliminary results presented at AACR-NCI-EORTC 2019, BI853520 results published in Target Oncol 2019, PLX3397 results published in Invest New Drugs 2019, TSR011 results published in Br J Cancer 2019).

3. We assessed the efficacy and safety of screening and eradication of Helicobacter pylori to reduce the incidences of gastric cancer and peptic ulcers. We further developed simple assay to detect drug resistant Helicobacter strains and new treatment regimens so that the physicians are able to conduct personalized therapies to patients. We conducted 6 trials and published 5 SCI articles in 2019.

Site Introduction

In recent years, the biotechnology development has always been the first priority for the national health care industry in Taiwan. However, as the most critical step in new drug development, human clinical trials in Taiwan have faced the bottleneck for the past few years because of the complexity and high costs.

In order to encourage the development of biotechnology industry and make up for the gap of downstream supply chian in new drug development process, National Taiwan University Hospital (NTUH) established the "National Center of Excellence for Clinical Trial and Research" in 2005 in response to the "Biotech Takeoff Diamond Action Plan" from the Executive Yuan, Republic of China (Taiwan) and played the leading role of biotechnology industry R&D and clinical implementation in Taiwan.

After focusing on innovative research and development strategies in clinical trials for these years, we have built a great clinical research environment and operating system, achieving distinctive results in doing new drug clinical trial research. In 2011, we won the 1st National Industrial Innovation Award in Taiwan. Besides, many international biotechnological pharmaceutical companies and clinical trial companies cooperated with NTUH to establish R&D centers in Taiwan because of the recognition for our innovative strategies and distinctive results. Combining global leading positions of international pharmaceutical companies in treatment areas of different diseases, our collaborations speed up new drug clinical research, benefiting patients around the world.

We conduct about 600 new drug clinical trials each year, including more than 40 new drug Phase I trials, including more than 40 international clinical trials. We hold positions of principal investigators and members of steering committee for international clinical trials. Now NTUH plays a leading role of clinical trials and research in the Asia Pacific Region and makes great contribution in the development and innovation of the biotechnology industry in Taiwan.

Clinicl Trial Expertise

Oncology, hematology, cell therapy, gastrointestinal tract disease, hepatology, rheumatology, metabolic disease, pulmonary disease, infectious disease, vaccine, cardiovascular disease, stroke, neurology, minimally invasive cancer surgery, early phase clinical trials.

International Accreditation

AAHRPP, FERCAP

GCP Inspection/audit

US FDA, PMDA, EMA

What types of clinical trial do you conduct?

Spotlights

CTC

The Helicobacter pylori (H. pylori) research team of National Taiwan University Hospital (NTUH) held an international consensus meeting regarding gastric cancer prevention through screening and eradication of H. pylori on Sep 30 and Oct 1st, 2019. With the two-day discussions hosted the NTUH, 30 overseas and Taiwan scholars conducted systematic reviews on several important issues regarding prevention of gastric cancer through screening and eradication of H. pylori. The experts have reached 26 consensus statements which will provide important evidence for gastric cancer prevention. Moreover, the experts proposed some important collaborative researches to resolve the unmet medical needs on this issue. It is hoped that the threat from gastric cancer could be substantially reduced by mass screening and eradication of H. pylori.

Publications

CTC

1

Serological responses to revaccination against HBV in HIV-positive patients born in the era of nationwide neonatal HBV vaccination.

2

The implementation of the consensus on the management of Helicobacter pylori and barriers to consensus

3

Dolutegravir-rilpivirine coformulation.

4

Arterial Switch, Ventricular Septation, and Fontan Takedown for Double Inlet Left Ventricle

5

Outcome of surgical intervention for aortic root abscess: a meta-analysis.

6

Toward population specific and personalized treatment of Helicobacter pylori infection.

7

Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial.

8

Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial.

9

Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial.

10

Fifteen new risk loci for coronary artery disease highlight arterial-wall-specific mechanisms.