Vietnam Clinical Research Introduction
Vietnam, a dynamic southeastern, Asian country of approximately 95 million inhabitants, continues to emerge on the world economic scene. Known for its history, culture and tourist destinations, it most recently branded itself as rapidly development economy as recently reported in Forbes.
With a predominantly young and tech savvy population, its culture appears to embrace an extensive and intensive entrepreneurial energy and attitude. Economic growth correlates with commitment to healthcare improvements. As recently reported by Dezan Shira & Associates: “demographic changes, rise in disposable income, and steady economic growth has led to a growing demand for healthcare services in Vietnam. In 2017, healthcare expenditure accounted for 7.5 percent of the GDP and between 2017 and 2021 it is predicted to grow at a compound annual growth rate (CAGR) of around 12.5 percent.”
Rapid growth in demand for improved healthcare services led to a natural introduction to clinical research generally and clinical trials industry specifically. Vietnam represents a rapidly emerging global economic participant; market for healthcare service improvements and prospect for significant clinical research participant. In addition to providing for a large population struggling with various health conditions, the country offers a sizeable healthcare community, nascent but evolving research infrastructure and considerably strong ties between physician and patients. TrialSite News research team recently reviewed and analyzed clinical research data in Vietnam.
Although still an emerging field in Vietnam, a search of ClinicalTrials.gov uncovered over 120 clinical trials that included Vietnamese sites in some capacity. Considerable challenges must be overcome for Vietnam to emerge as a sustained, major research center. There is still a lack of awareness about the clinical trials industry within Vietnam, however, we believe that this is changing. Assistance levels from the Vietnamese Ministry of Health probably need to mature and deepen in capabilities, scope and breadth of support offerings. Although there are nearly 200 hospitals in Vietnam, we suspect that many are unfamiliar with clinical research. In some cases, medical providers may not possess the requisite facilities, capabilities or experience required of the global clinical research industry. We believe that presently, only a small percentage of existing provider institutions and physicians participate in clinical research.
Healthcare Infrastructure Improving
Vietnam has made considerable progress toward improving health status of the population— surpassing some of the neighboring southeast Asian countries. See a report published with the National Institutes of Health in 2013. This report highlights the following:
- Life expectancy in Vietnam is 72.8 (considerably higher than many countries with similar GDP levels per capita
- 1990 to 2009 infant mortality rate fell from 44.4 percent to 16 percent
- Under-five mortality rate dropped from 58% to 24.5%
- Maternal mortality rate declined from 233 to 69 deaths per 100,000 live births
- Malnutrition has dramatically fallen
Vietnamese health investment continues to grow with its expanding economy and commitment to population health. Researchers note that the ongoing improvements in public health derive from a widespread healthcare delivery network, increasing qualified health workers and ongoing expansion of national public health programs. Regarding financing public health another report highlights some key metrics.
Per capita health expenditures increased from US $14 in 1995 to US $86 in 2012. Total health spending, as a percentage of Vietnamese GDP, rose from 7.4 percent in 1995 to 10 percent in 2012. Dramatically, health insurance coverage grew from 10 percent in 1995 to 68.5 percent in 2012. Core challenges remain, including health equity issues for catastrophic situations. We provide a recent report authored by the Health Policy Project covering Vietnam health financing conditions.
Vietnamese per capita amount spent on healthcare has doubled— driven in great part by the country’s rapidly emerging economy and associated consumer demand for improved health services. Over the past years, Vietnam has undergone healthcare reform through the government-driven “Direction of Healthcare Activities” (DOHA). DOHA refers to “guidance line” or “level” and requires a healthcare hierarchy including the following:
This reform necessitates that each government administration tier supports the tier directly below to help lower tier hospitals and clinics to provide medical services for local communities in primary care settings and therefore, reduce the number of patients in high tier (central and provincial) provider systems. The Vietnamese government addressed the challenge that too many patients were visiting the central and provincial hospitals. A core objective of DOHA included technical skills transfer training to mitigate and transform the distribution of patients in the system to district and community levels. The authors concluded that the DOHA plan has in fact streamlined and expedited the skills transfer at lower tier medical centers across Vietnam.
The biopharmaceutical product market grows at a healthy pace in Vietnam. Pan Asian direct investment consultancy Dezan Shira & Associates articulates that with progressive government policies and more changes on the horizon, Vietnam “offers many opportunities for potential suppliers.” Their recent report places the existing Vietnamese market for pharmaceutical products at US $5.2 billion with health growth projected. However, Vietnam still represents a “mixed” economy combining elements of socialism with market-based economies. The public hospitals became overburdened and some years ago private investors sought to profit on the situation by investing in and building new hospitals. According to at least some reports, these private sector investments in healthcare are struggling—see recent VietNamNet article.
Clinical Research Regulatory Environment Vietnam
The transforming Vietnamese economy, evolving health consumption model and ongoing health provider system improvement represents opportunity for clinical research. Jonathan Kagan, associate director, Division of Clinical Research, NIAD at National Institutes of Health, and team authored a report in 2016 titled Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries. Kagan and an impressive team of co-authors associated with NIH/NIAID, as well as the Vietnam Ministry of Health and U.S. Department of State (U.S. Embassy & Consulate Vietnam) assessed Vietnam’s clinical research capacity utilizing six elements including:
- Research Agenda
- Clinical Investigators & Biostatisticians
- Donors & Sponsors
- Community Involvement
- Scientific, Ethical, Safety & Quality Oversight
- Clinical Research Institutions
The U.S. and Vietnamese research team incorporated inputs for assessments from interviews with key stakeholders in the Vietnamese clinical ecosystem as well as extensive literature review. As Kagan and some of the team maintain, the ClinRegs site (covered later in this article) they represents an exceptionally knowledgeable body of knowledge involving global clinical trial regulatory process worldwide. See Clinregs Vietnam.
The team concluded that growing numbers of clinical trials in Vietnam “improved regulation in human subject protection and community engagement” and that overall that there are “modest advances in research agenda setting.” They noted that ongoing training, knowledge transfer and institutional investment remains challenging. The research team found that from 2010 to 2015 the number of clinical trials with a Vietnamese investigator increased from 5 to 11, the actual percentage of investigators in Vietnam remained the same over that five-year period. They point out that “training and investment in institutions remain challenging” and imply that Vietnam must develop a more sophisticated “framework” to not only identify strengths and gaps but also direct activities ranging from “capacity-building efforts” to policy making, to the inevitable investments in clinical research.
Kagan is one of the principles behind government-funded ClinRegs, a NIH/NCBI sponsored “online database of country specific clinical research regulatory information designed to assist in the planning and implementing international clinical research.” TrialSite research has utilized this website for several research projects— it provides a solid summary overview of clinical trials regulatory requirements in select countries including Vietnam. See their report for Vietnam. In Vietnam, the Ministry of Health (MOH) is responsible for clinical trial regulatory oversight. Moreover, other segments are divided into various bodies including:
- National level ethics committee (EC)
- Administration of Science, Technology and Training (ASTT)
- ASTT responsible for registering CROs supporting studies and services
Vietnam Minister of Health oversees the following national research centers:
- National Hospital of Tropical Diseases
- National Institute of Hygiene and Epidemiology
- Hanoi Medical University
- National Hospital of Pediatrics
- National Center for Veterinary Diagnosis
- National Lung Hospital
Based on recent TrialSite News survey, approximately 395 trials have been conducted in Vietnam. This includes all present and past studies. Currently, there are 123 clinical trials that involve at least one research site in Vietnam. Furthermore, 88 clinical trials are active with more than one site in Vietnam, 64 trials have some form of commercial sponsor participation and the rest represent either government or academic institutions. At least 23 clinical trials include Vietnamese sponsorship or collaborator status. Active Vietnamese sponsors or collaborators include:
- National Hospital for Tropical Diseases (NHTD)
- Hanoi Medical University
- Oxford University Clinical Research Unit (division of NHTD)
- National Institute of Hygiene & Epidemiology
- Van Hanh General Hospital
- Hue University of Medicine & Pharmacy
- Hai Phong University of Medicines & Pharmacy
- Vinmec Research Institute of Stem Cell and Gene Technology
- 108 Military Hospital
- Da Nang Hospital
- Viet Tiep General Hospital
- Cho Ray Hospital
- Pham Ngoc Thatch Hospital
- Hung Vuong Hospital
- Phuc Long Hospital
Further, we provide a select summary of these Vietnamese institutions. Several western commercial sponsors are active in the country. We found it interesting that European commercial sponsors outnumber their American counterparts. The most active included:
- AstraZeneca (this Anglo/Swedish sponsor represents the most active)
- Novartis (Switzerland)
- Roche (Switzerland)
- Bayer (Germany)
- Boehringer Ingelheim (Germany)
Other commercial sponsors involved with one or two trials in addition to institutions such as the French National Institute for Health & Medical Research and Oxford University’s Clinical Research Unit (also categorized as local institution). Many therapeutic areas are involved, but some key ones include communicable and infectious disease, respiratory and lung disease, gastrointestinal disease and disorders, metabolic and liver diseases, oncology and neurology.
Major Research Centers/Sites
We tracked over 20 research centers and sites, from major government health systems to small research specialists. Only a handful of research sites were conducting more than a few research trials at a time. The following research institutes appear most active based on our recent review.
|Research Site||Summary||Website & Contacts|
|National Hospital Tropical Diseases||Central Gov Institution founded 1862 (NHTD) is the highest examination and treatment line, rehabilitation of infectious diseases and tropical, health worker training, mentoring, disease prevention and scientific research, application deployment science, technology, modern engineering specialties serving patients infectious and tropical. The hospital contains 280 impatient-beds with 7 function rooms, 5 clinicals, 5 paraclinical and a training center.||http://benhnhietdoi.vn/
Dr. Nguyen Van Kinh, MD, PhD, Director
|Oxford Clinical Research Unit||The Oxford University Clinical Research Unit-Vietnam (OUCRU) was established in Ho Chi Minh City in 1991. It is hosted by the Hospital for Tropical Diseases (HTD), originally founded in 1862. HTD is the referral hospital for infectious diseases for all southern Viet Nam. Read more about milestones in Vietnam:||https://www.tropicalmedicine.ox.ac.uk/research/oucru
Dr. H. Rogier van Doorn, Sr. Scientist
|Hanoi Medical University||The oldest university of Vietnam and is located in Hanoi. HMU was founded in 1902 by French during the French colonization under the name Indochina Medical College. The first headmaster of HMU was Alexandre Yersin who was the co-discoverer of the bacillus responsible for the bubonic plague or pest, which was renamed in his honour (Yersinia pestis). Currently sponsoring at least one major study.||http://www.benhviendaihocyhanoi.com/
Bui My Hanh, Director, Science Research and International Cooperation Unit
|National Institute of Hygiene & Epidemiology||The National Institute for Hygiene and Epidemiology (NIHE) focuses on prevention and control of communicable diseases. In addition to scientific research in epidemiology, medical microbiology, immunology, and molecular biology, NIHE conducts various national programs on infectious disease surveillance and control, develops vaccines, and conducts public health training and education on both undergraduate and post-graduate levels.||http://nihe.org.vn/en/home-c10902.htm
Professor Dang Duc Anh, Director
|Hue University of Medicine & Pharmacy||Founded in 1957, the school has educated more than 9,000 medical doctors and more than 3,000 post-graduates. Hue includes the following institutes: Community Health Research; Biomedical Research & Biotechnology; Family Medicine; Nursing & Reproductive Endocrinology & Infertility.
Rector, Professor Cao Ngoc Thanh
|Hai Phong University of Medicines & Pharmacy||Established in 1979, they currently have about 320 administrative staff. Recently participated in clinical research design conference.||http://hpmu.edu.vn/en
Director, Nguyen Van Hung, MD PhD
|Vinmec Research Institute||A new formed subsidiary of Vingroup Corporation, it was formed and financed to apply the most advanced technologies of biomedicine and regenerative medicine into healthcare for the Vietnamese people. They are involved with extensive stem cell research and several clinical trials in Vietnam. VRISG is owned by Vingroup, a Vietnamese conglomerate with focus on real estate development. Controlled by Phạm Nhật Vượng, one of the wealthiest individuals in Vietnam, it operates 1,000 retail stores across Vietnam. It has spun off health ventures including VRISG. Although a young organization it is making some waves in the market. Toward the end of 2017, VRISG became the first medical facility worldwide to successfully complete a bone marrow mononuclear cells transplantation to treat established bronchopulmonary dysplasia (BDP).||https://vinmec.com/research/vrisg/
Gene Technology Department Head, Le Thi Thanh Huong
Stem Cells & Immune Cell Department Head, Bui Viet Anh
Bioinformatics & Medical Statistics Department Head, Le Sy Vinh
|108 Military Hospital||Originally a military hospital for the French army in Indochina built in 1894 (Lanessan Hospital or Nhà thương Đồn Thủy) and the practice hospital for Indochina Medical College (now Hanoi Medical University); after the Revolution it was take over in 1954 and turned into a central military hospital for senior officials and now open to the general public. Considered one of the most famous hospitals in Vietnam, it is the first to carry out an organ transplant and is famous for surgery.||Clinical Research contact:
Le Huu Song, Associate Professor MD,PhD
Professor Song is Director of the Vietnamese – German Center of Excellence
|Da Nang Hospital||Established in 1945 in the Vietnamese city of Da Nang. They are catering to significant international patient base||http://dananghospital.org.vn/
Ngoc Ba Nguyen, Vice-director
|Viet Triep General Hospital||Little information in English available but they are involved with a few clinical trials based on extensive web searches.||Mr.Pham Hai Dang Chief, Department of Foreigner Services|
|Pham Ngoc Thatch Hospital||Little information in English available but they are involved with a few clinical trials published in Clinicaltrials.gov||http://www.bvpnt.org.vn/
Dr Nguyen Huy Dung, Principal Investigator
|Cho Ray Hospital||The largest hospital in Ho Chi Minh City, founded in 1900 during the French colonial rule as Hôpital Municipal de Cholon. Over the years, the hospital has also been known as Hôpital Indigène de Cochinchine (1919), Hôpital Lolung Bonnoires (1938), and Hôpital 415 (1945), until it was ultimately renamed Cho Ray in 1957. The facility was reconstructed on the area of 53,000 m² and was re-equipped to become one of the largest hospitals in Southeast Asia in June 1974 with the help of the Japanese government. At present, the hospital has 35 clinical, 11 subclinical and 8 functional departments. It organizes practice and postgraduate training for more than 2,500 medical students and 600 doctors each year. Cho Ray Hospital has 1200 beds, employs 2,270 health workers including 500 medical doctors and pharmacists, and provides treatment for about 457,000 outpatients and 67,000 inpatients per year. Active international contacts are held with medical facilities all over the world.||http://www.choray.vn/
Tran Van Ngoc, MD, PhD (principal investigator)
Hung Le Quoc, MD
|Hung Vuong Hospital||Little information in English available but they are involved with a few clinical trials published in Clinicaltrials.gov||http://www.bvhungvuong.vn/|
|Phuc Long Hospital||Little information in English available but they are involved with a few clinical trials published in Clinicaltrials.gov||Could not find website
Dong Xoai, Binh Phuoc
|Viet Duc Hospital||The largest surgical center in Vietnam. Founded in 1904 as part of Indochina Medical College by the French colonial governor at the time Paul Doumer. It bore different names in history. Currently the hospital has more than 500 beds for patients and 18 surgery rooms and supports 800 open-heart surgeries annually. It has collaborations with medical facilities in France, Germany, Australia and other countries. In 1998 the Medicinal Laser Unit was established applying laser techniques to in the diagnosis and treatment of some diseases including cancer.||http://eng.benhvienvietduc.org/
Report evaluating training programs at Viet Duc Hospital in 2016
Vietnam is a dynamic country growing both in population and from the standpoint of GDP and economy. The 14th most populous country worldwide in 2018, it ranks about 49th in GDP, but represents a growing company with an energetic young population. There have been ongoing health sector transformations and the populace seeks to continuously improve health care by demanding more options as the country’s wealth increases.
With nearly 95 million, it represents a large market in which there are significant health challenges that global clinical research agendas could help address. Vietnamese seek new opportunities to become healthier and participate in the global health industry. Recognized experts in the clinical research arena have generated comprehensive research studies on the potential for Vietnam to be a major participant in clinical research— although they do note it is still the early days in regards to the clinical research maturity curve. Yet, there is a drive and a dynamic aspiration for more within a vast majority of Vietnam’s population, and this will reflect in growing participation in scientific and clinical research endeavors. Vietnam’s population possesses an entrepreneurial culture that will manifest itself in more health care and clinical research pursuits ongoing. New opportunities for the global clinical research industry are present, but the investments represent long-term affairs.