Clinical trial regulatory in Vietnam

Recently, the Thailand FDA has brought a revised list of Institutional Review Boards (IRBs)/Ethics Committees (ECs) that it recognizes for acceptance of clinical trial applications.

Clinical trial regulatory in Vietnam

In our previous articles (see Part I and Part II), we’ve discussed the regulatory scenario in Thailand, including regulatory approvals for the clinical trial in Thailand, ethics committee approval for the clinical trial in Thailand, documents required for regulatory submission, and ethics committee submission in Thailand. We’ve also presented a list of ethics committees that are recognized for application to the Thailand FDA.

Now, with the revised notification, the list of currently recognized ethics committees in Thailand is being updated.

List of Ethics Committees recognized by Thailand FDA

# Name of IRB, or name of institute / Hospital / University, where IRB is established Recognition starts from Recognition end on
1. Bangkok Hospital, Bangkok 07 Oct 2016 06 Oct 2018
2 Phramongkutklao College of Medicine, Bangkok 05 Oct 2016 04 Oct 2018
3. IHRP, Bangkok 07 Oct 2016 06 Oct 2018
4. Bumrungrad Hospital, Bangkok 07 Oct 2016 06 Oct 2018
5. Khon Kaen University, Khon Kaen 11 Nov 2016 10 Nov 2018
6. Siriraj Hospital, Mahidol University, Bangkok 24 Nov 2016 23 Nov 2018
7. Mahidol University’s Center of Ethical Reinforcement for Human Research, Bangkok 29 Nov 2016 28 Nov 2018
8. Ramathibodhi Hospital, Bangkok 07 Dec 2016 06 Dec 2018
9. MOPH IRB, Bangkok 06 Dec 2016 05 Dec 2018
10. CREC, Bangkok 07 Dec 2016 06 Dec 2018
11. Naresuan University, Pitsanulok 10 Apr 2015 09 Apr 2017

Important modifications in the new list

  • While, Thailand FDA revises the list of IECs / IRBs almost every two years, this time the revision is of greater significance. Let’s see why it is so.
  • For the first time, ethics committees (ECs) from private hospitals have been recognized by Thailand FDA.
  • There are two such private hospitals’ ECs, namely Bangkok Hospital and Bumrungrad Hospital.
  • Big university hospitals, like Chiang Mai University, Prince of Hat Yai University Songkhla, and Chulalongkorn University have been given a miss this time.
  • Govt. IECs/IRBs, including the MOPH ethics committee and, new one on the bloc – CREC are still continuing. Read more about CREC in our previous post.
  • IHRP has been included this time as well, however, currently, there are no new applications being accepted there, as reported by some of our industry contacts.
  • Naresuan University, which was included in the last modification, continues to be approved until 9 Apr 2017. Its further continuation in this list may be decided later on.
  • University and Govt. hospitals/sites, still continuing in the list of recognized ECs, include Siriraj hospital, Khon Khaen University, PMK (armed forces’ hospital), Ramathiodhi hospital, and Faculty of Tropical Medicine, Mahidol University.

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Impact of a new list of recognized ECs

Private hospitals

There is no doubt that some trial management teams find it more convenient if their clinical sites are at private hospitals. Decision-making is faster, investigators can be more approachable, many institution-related works can be finished quickly, or they just find the staff more professional.

The inclusion of Bangkok Hospital and Bumrungrad Hospital in this list opens new avenues for trial planners and site selection teams. Both of these are very experienced, well-equipped, and professional sites capable of handling big trials.

Central Research Ethics Committees (CREC)

As discussed in our previous article, this new central ethics committee is one of the best things that happened to the Thailand clinical trial scene in the last few years. It’s recognized by FDA, affiliated to several sites in Thailand, and still not heavily loaded with clinical trial applications. This means, shorter queues for submission, quicker approval times, and, best of all, flexibility to work at several excellent sites in Thailand.

Saving time…and cost!

If a site is not affiliated with an EC that has been recognized by Thailand FDA, then mostly investigator needs to apply to two ECs for approval, Local EC and Central EC (recognized by FDA). In such cases, there may be a delay in project approval due to the submission queue at the central EC office. It means that an additional time period of 3-9 months may have to be factored in planning.

However, if a trial has been planned at a site that is affiliated with an FDA-recognized EC, then the trial team can save a lot of time in securing necessary EC approval, as well as cost required for such planning, execution, and management.

Trial managers, do factor these sites in your project planning. 🙂

How to benefit from these developments?

Start exploring Thailand for clinical trials

If you’ve not done so, this is a good time to start your clinical trials in Thailand. There is an increased awareness about supporting clinical trials by the Govt. authorities.

Explore new clinical sites as well

Thailand is a very good option to place your clinical trial if it’s a global clinical trial or one intended to be submitted to Thailand FDA. It’s the country with the highest number of clinical trials in the ASEAN region.

There are plenty of potential investigators, trained sites, and very mature awareness of global clinical trial systems and regulations. Although some sites (like Siriraj Hospitals, Ramathobodhi Hospital, etc) are quite famous (and, very busy too), trial managers can (and should) explore other options as well.

Try exploring clinical trial feasibility with investigators in Thailand. You can do so easily with Credevo. To do so, post your project with preliminary details.

Connect with Thailand consultants

You can make the most of these advantages if you have a trial team based in Thailand. If you don’t have it yet, you can still explore Thailand with the help of several consultants. These consultants are industry experts/veterans, who have worked in various capacities in the pharma / clinical research industry.

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