Thailand Clinical Trial Regulatory Scenario: Update 1
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.
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.
The Thai FDA has updated the list of currently recognized ethics committees in Thailand in the revised notification.
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
- Thailand FDA revises the list of IECs / IRBs almost every two years, and this time revision is of greater significance. Let’s see why it is so.
- The Thai FDA recognized ethics committees (ECs) from private hospitals for the first time.
- Two such private hospitals’ ECs are namely Bangkok Hospital and Bumrungrad Hospital.
- Thai FDA, in the new list, skipped the big university hospitals like Chiang Mai University, Prince of Hat Yai University Songkhla, and Chulalongkorn University.
- Govt. IECs/IRBs like the MOPH ethics committee and the new one on the bloc – CREC are continuing. Read more about CREC in our previous post.
- The list includes IHRP this time as well however, currently, no new applications are being accepted there, as reported by some of our industry contacts.
- Naresuan University, present in the last modification, continues to be approved until 9 Apr 2017. Thai FDA may decide its further continuation in this list later on.
- University and Govt. hospitals/sites, continuing in the recognized ECs list, 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
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, clinical investigators can be more approachable, many institution-related works can be finished quickly, or 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 are very experienced, well-equipped, and professional sites capable of handling large 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. It 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 an affiliate to a Thai FDA recognized EC, the 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 one needs to consider additional 3-9 months for planning.
The sponsor can save a lot of time securing necessary EC approval if a sponsor plans a clinical trial at an FDA-recognized EC affiliate site. The sponsor can also save the cost for planning, execution, and management.
Trial managers do factor these sites into 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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