Clinical_Trial_Vietnam_Credevo

Vietnam, known for its tourism destination, now is also a destination for clinical trials and research. With a sizeable population of 85 million, Vietnam provides a vast pool of participants, healthcare professionals and strong doctor – patient relationships, which result in a greater retention rate. [1]

Clinical_Trial_Vietnam_Credevo

Clinical Trials in Vietnam

Since last few years, Vietnam has been a site for most of the clinical trials that have been planned in South-East Asia. Along with Philippines and Thailand, it is considered as one of the ‘hot’ and upcoming countries for conducting clinical trials in ASEAN.

According to clinicaltrials.gov, a total of 449 clinical trials have been conducted in Vietnam, 125 of which are ongoing or active trials. The ratio of ongoing to total trial indicates the huge positive shift in attention that Vietnam has gained recently from clinical research companies. [data as on 15-Oct-19][4]

Major therapeutic areas for clinical trials

Most of the trials in Vietnam have been focused around certain specific therapeutic areas. Major therapeutic segments considered for conducting clinical trials in Vietnam are as follows.

  • Communicable and infectious diseases
  • Respiratory and lung disease
  • Gastrointestinal disease
  • Immune disorders
  • Metabolic and liver diseases
  • Neurology

Starting Your Clinical Trial in Vietnam

For those, who would like to conduct clinical trial in Vietnam for the first time, it is very important to understand the regulatory, ethics and local concerns around starting a trial in Vietnam.

First and foremost, the regulatory area..

Clinical Trial Regulatory

Regulatory authority responsible for clinical trial approvals, oversight and inspections in Vietnam is the Vietnam’s Ministry of Health (MOH). Further, specific areas have been divided into different bodies.

  • National level ethics committee (EC), the Ethical Evaluation Committee in Biomedical Research (EECBR), is responsible for approving the protocol and study documentation.
  • The Administration of Science, Technology and Training (ASTT) reviews clinical study documents, organizes the Ethical Evaluation Committee in Biomedical Research (EECBR) meeting and conducts its review of the Investigator’s Brochure (IB) portion of the dossier.
  • ASTT is also responsible for registering contract research organizations (CROs) that support clinical studies and provide other research services.

Clinical trial registration is not required.

The scope of the MOH’s assessment includes all clinical trials (Phase I – IV) for the following:

  • Drugs that contain a new active ingredient or new combination of marketed ingredients.
  • Newly developed biologics or biologics with a new combination of marketed ingredients.
  • Newly developed vaccines that are manufactured and used for the first time.
  • Oriental medicines or traditional drugs made from medicinal materials containing new ingredients to be used in humans for the first time.
  • Drugs, biologics and vaccines which have been legally marketed for a period of less than five 5 years in the country of origin.
  • Drugs, biologics, vaccines, medical devices, combination products and oriental medicines for which a clinical trial has been conducted, but have not met the MOH’s or internationally recognized good clinical practice (GCP) requirements.

In order to begin the regulatory process, sponsor must select the investigators and host institutions, where clinical trial will be conducted. This process is not very different to site selection process employed elsewhere.

Site selection and Investigator

Vietnamese regulations require the sponsor to select investigator(s), principal investigator (PI), consultant experts and host institutions. These selections must be performed taking into account the appropriateness and availability of the study site and facilities.

  • Vietnamese sites are located in northern and southern regions in and around big cities of Hanoi and Ho Chi Minh City, respectively. These sites, along with many more other sites, provide a significant pool of patients for various kinds of clinical trials.
  • It might help to get local or expert support in reaching to these sites. Credevo provides an exhaustive coverage of sites within Vietnam. More than 300 investigators within this small country are accessible through Credevo.

Interested in conducting clinical trial in Vietnam? Provide brief details of your requirement and Credevo will help you get started.

After selecting investigators / host institutions, process to apply for approvals, including EC approval gets started.

Now, let’s understand bit more about EC processes in Vietnam first.

Ethics Committee

To conduct a clinical trial in Vietnam, an approval from institutional and national level ethics committee (EC) is required.

  • Institutional level EC approval is performed by an EC that is registered as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) with the MOH’s ASTT.
  • National level EC approval is conducted by the MOH’s Ethical Evaluation Committee in Biomedical Research (EECBR).
  • The EECBR’s activities consist of conducting plenary meetings, subcommittee meetings and periodic and ad-hoc investigations.
  • CEBRGLs and the EECBR and are responsible for ensuring independent, timely and competent reviews of all ethical aspects of the clinical trial protocol.

Regulatory Approval Process

Since, the national EC as well as RA approval process is performed together by MoH, it helps a lot to understand RA process.

Clinical_Trial_Application_Process_Vietnam_Credevo

First, the sponsor is required to submit following documents to ASTT

  • Registration files that include the clinical trial application (CTA) form.
  • Principal investigator (PI) details,
  • Host institution proposal and
  • Investigator’s Brochure (IB)

Upon receipt of the appropriate files,

  • ASTT will respond to the sponsor in writing within 15 working days.

After clearance of registration files,

  • Sponsor is responsible for coordinating with the principal investigator to prepare the required clinical trial files. Sponsor should also submit the IB to ASTT.
  • Clinical trials submitted before 20th of each month will be reviewed in that month. Trial files submitted later than 20th will be reviewed in the following month.

Upon receiving all required documents,

  • ASTT will assign a group to review the IB and will simultaneously organize the EECBR meeting to review and approve the protocol and other trial files.

After receiving the IB and the EECBR’s reviews,

  • the ASTT will finalize the dossier, and send written notice of the results to the sponsor, the principal investigator and/or the host institution.
  • ASTT’s review will be finalized once national level EC approval is obtained.
  • Approved clinical trials files will be forwarded to the MOH minister and gives final approval to the entire dossier.

The entire MOH review and approval process should take approximately 60 working days.

Type of Application Process

The ASTT review is conducted in parallel with the EECBR review. This helps a lot in minimizing approval time.

Application Language and Exceptions

The official language is Vietnamese.

English or Vietnamese is acceptable for specific documents, these include:

  • Sponsor-prepared clinical trial application form (English)
  • IB (English and Vietnamese)
  • Main study site-prepared clinical trial application form (English and Vietnamese)
  • Study protocol (English and Vietnamese)
  • Informed Consent (IC) form (Vietnamese and English)
  • Drug manufacturing procedures (Vietnamese and English).

However, the study information sheet should be in Vietnamese.

Approval Timeline

The entire MOH review and approval process should take approximately 60 working days from date the sponsor and the principal investigator submit documentation to the ASTT and the EECBR.

MOH minister issues final approval in about 10 working days.

Processing Fee

  • EECBR currently charges a fee of $1,000-$2,000 USD.
  • EC that is registered as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) charge a fee of $500-$2,000 USD depending on the complexity of the trial.
  • For locally-manufactured medical devices, a fee of 300,000 VND per dossier and import permits are 200,000-3,000,000 VND. [3]

Trial Initiation

After necessary approvals from ASTT and national level EC have been secured, it becomes possible for clinical trial management team (from sponsor or CRO) to initiate the clinical trial. However, at this stage, it’s necessary to ensure that permission to import any medicinal drugs and other supplies have been obtained as well.

Import License

Sponsor should obtain an import license for the shipment of an investigational product used in the trial from the MOH’s Drug Administration of Vietnam (DAV).

Letter of Agreement

After securing EECBR approval, the sponsor is required to sign a letter of agreement with the participating host institution(s) before the trial begins.

Safety reporting

After clinical trial has been started, Vietnamese regulations require investigators to submit periodic safety updates to the national ethics committee (EC) – EECBR.

Principal investigator must send progress reports of the trial to the sponsor and EECBR, every 3 months from the date of the trial’s initiation.

This report should contain the following

  • Investigational product (IP) safety and side effects
  • Serious Adverse Events (SAEs)/Serious Adverse Drug Reactions (SADRs)/Suspected
  • Unexpected Serious Adverse Reactions (SUSARs). [2]

Need More Details?

Hopefully, this will help those interested in conducting clinical trials in Vietnam.

In case, you’re interested in getting more details on Vietnam or reaching out to investigators in other countries, contact us with your requirements.

You can also sign up on Credevo and post your project to assess your clinical trial feasibility in any country or therapeutic area.

For specific questions and other details, click here to contact us.

To explore more South East Asian regions, follow the links below

References

  1. https://epsi-global.com/locations/vietnam/article01.html
  2. https://clinregs.niaid.nih.gov/country/vietnam#timeline_of_review
  3. https://www.linkedin.com/pulse/20141030050535-5583531-update-clinical-trials-in-vietnam/
  4. https://clinicaltrials.gov/ct2/results/browse?cntry=VN&brwse=cond_alpha_all

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