Brian Jeffrey
Southeast Asia is quickly becoming a key player in the field of clinical trials, yet Vietnam is struggling to keep up with this progress. This sentiment was expressed by various specialists during a discussion panel titled “Enhancing Innovation in Vietnam via Clinical Trials.”
Dr. Phan Tan Thuan, who leads the Clinical Trial Unit at Ho Chi Minh City Oncology Hospital, revealed that the facility is currently participating in 37 international clinical trials, most of which are phase 3 studies.
These trials have opened doors for numerous patients to access cutting-edge medications that are not yet available in Vietnam, with treatment cycles reaching costs of up to 12,000 USD every 3–4 weeks.
Dr. Le Thanh Nhan, heading the Scientific Research Unit at Children’s Hospital 1 in Ho Chi Minh City, highlighted that the hospital is conducting five clinical studies in partnership with international entities.
Professor Guy Thwaites, the Director of the Oxford University Clinical Research Unit in Vietnam, stated that clinical trials present significant advantages. In his report “Future Directions for Clinical Trials in Vietnam,” he explained that patients benefit from access to groundbreaking treatments that can save lives and reduce costs.
Regulatory bodies can utilize these trials to foster a solid clinical trial framework, enhance public health, and facilitate effective healthcare policy creation. The pharmaceutical sector also gains from workforce development, innovation encouragement, and increased foreign investment.
However, despite the advantages, Vietnam’s clinical trial landscape experienced a downturn from 2018 to 2023, conducting only 40 trials and witnessing a compound annual decline of 3.4%. Most of these trials have concentrated on cancer as well as infectious diseases like COVID-19, tuberculosis, hepatitis, dengue, and drug-resistant infections, alongside cardiovascular conditions.
Professor Thwaites pointed out various obstacles impeding Vietnam’s advancement:
Prolonged approval timeline: In Vietnam, obtaining ethical and regulatory approval for clinical trials can take approximately 160 days, which is more than double the global average of 75 days. For context, this process takes 18 days in Singapore, 20 days in Indonesia, and 31 days in Japan.
This delay stems from the two-tier review system involving both central and local ethics committees, intricate administrative processes, inadequate infrastructure, and staff shortages.
Restrictions on importation of investigational medicinal products (IMPs): Unclear regulations concerning the import of testing kits and related devices create challenges for sponsors. Inconsistent documentation requirements across various regulatory agencies lead to unpredictability.
Insufficient incentive programs: Vietnam provides fewer advantages than its regional counterparts, making it less appealing to multinational pharmaceutical corporations.
Limited expertise in clinical trials: Many healthcare workers, particularly younger doctors and nurses, lack training and experience with clinical trial operations.
Low enrollment rates: Only about 1–2% of eligible patients take part in trials. Factors like public hesitance, restricted information access, high dropout rates, and related costs result in prolonged timelines and increased expenses.
Growing health demands necessitate immediate action.
At the same time, Vietnam’s health challenges are escalating. Annual mortality rates are expected to rise from 522,800 in 2024 to 563,400 by 2027. Non-communicable diseases, including cardiovascular issues, lung cancer, and chronic respiratory conditions, are responsible for about 70% of total fatalities. This data underscores an urgent necessity—and opportunity—for the expansion of specialized clinical trials.
Professor Thwaites stressed the importance of Vietnam swiftly refining its legal processes, improving infrastructure, educating clinical trial personnel, and boosting incentive frameworks to align with global trends.
Experts believe that if Vietnam can effectively implement these changes, it has the potential to conduct up to 86 clinical trials, creating thousands of quality jobs, enhancing the nation’s standing in medical research, and granting patients earlier access to advanced therapies.
