taiwan-clinical-trial

Taiwan has one of the most progressive healthcare systems in the world and is a major hub for clinical research in the Asia-Pacific region. Currently, it is well positioned to meet the growing demands of the global clinical trial market.

taiwan-clinical-trial

Why choose Taiwan

There are many good reasons to go to Taiwan for clinical trials. Here are the top five.

  1. Large talent pool of well-trained clinical practitioners

    Many investigators, internationally experienced, well-informed and trained, fluent in English – hard to ignore!

  2. State-of-the art infrastructure

    Tens of well-established hospitals in such a small country speak volumes about their attention on improving infrastructure. These hospitals, some of which are associated with universities too, are well-equipped and carry out some of the best researches in the world. There is strong government policy support for the development of a conducive environment for carrying out clinical trials.

  3. Vast clinical trial experience

    Plenty of trials have been performed in Taiwan and many more are ongoing. Have you been too late to go there?

  4. Strategic location

    Taiwan is well-placed in Asia with close proximity to China, Korea and Japan. Conducting trials there may help you connect with China faster. We’ll talk about it more.

  5. International ethical standards

    Taiwanese clinical investigators are familiar with ICH-GCP (International Committee on Harmonization of Good Clinical Practice) guidelines and many are internationally trained to carry out multi-institutional clinical trial procedures. Taiwan has well-established clinical research centers with high quality standards that strictly follow the accepted international guidelines of ICH-GCP.

Clinical Sites in Taiwan

Here are some interesting info about sites in Taiwan.

  1. Currently, there are 134 hospitals in Taiwan that are qualified by the TFDA to conduct clinical trials.1
  2. Furthermore, the National Research Program for Biopharmaceuticals has set up 13 disease-specific Taiwan Clinical Trial Consortiums to assist international pharmaceutical companies to perform clinical trials in Taiwan.2
  3. In 2005, the National Taiwan University Hospital established the National Center of Excellence for Clinical Trial and Research (NCECTR) to meet the challenges of the growing demand for clinical trial centers with international standards.
  4. This reputed center, NCECTR, conducts over 600 new drug clinical trials each year, including more than 40 Phase I trials, and over 40 international clinical trials.
  5. Some of the famous hospitals which carry out clinical trials include:
    • Koo Foundation Sun Yat-Sen Cancer Center
    • Taipei Veterans General Hospital
    • Linkou Chang Gung Memorial Hospital
    • Tri-Service General Hospital
  6. According to the Regulations on Human Trials, all experts conducting clinical trials in Taiwan should receive human trial-related training of more than 30 hours within six years of starting a trial.

It’s possible to connect with many of these sites and investigators at Credevo. You can simply signup as a trial manager and post a project for free. This will invite feasibility feedback from Taiwanese investigators, who can be contacted for more details.

Clinical Trial Regulations

Currently, Taiwan ranks second in terms of the number of multinational clinical trials conducted in East Asia.In order to manage approval and oversight of such big numbers of clinical trials, a firm regulation framework has been put in place.

Emphasis has been given not only to the approval, but to actual conduct of clinical trials too. For instance, according to the Regulations on Human Trials, all experts conducting clinical trials in Taiwan should receive human trial-related training of more than 30 hours within six years of starting a trial.

Lists of laws related to conducting clinical trials and BA/BE studies in Taiwan are available at

  1. Laws and regulations database website, and
  2. Center for drug evaluation (CDE) website

Take-Aways

Taiwan is emerging as a big player in the Asian clinical trial market. The major advantages of conducting clinical trials in Taiwan are:

  • World class, high quality infrastructure
  • Low cost
  • Dense population, easy patient recruitment process
  • Internationally trained healthcare personnel fluent in both English and Chinese
  • Trials comply with ICH-GCP standards

Clinical Trial Approvals in Taiwan

We’ve discussed this important topic in Part 2 of this article. Check it out! 🙂

References

  1. http://www.fda.gov.tw/upload/133/Content/2014033109035995639.pdf
  2. http://tc2.ntu.edu.tw/en/
  3. https://clinicaltrials.gov/ct2/results/map?term=multinational+trials&map=ES
  4. SIDCER Recognition Programme. http://www.sidcer.org/new_web/index.php?group=main&open=recognition.php
  5. AAHRPP Accredited Organizations. http://www.aahrpp.org/learn/find-an-accredited-organization
  6. Yang Y-T, Huang H-W, Chen Y-T, et al. Regulation of new drug approval in Taiwan. Ther Innovation Regulatory Sci 2016; 50:602-608.