Clinical trial is the practice of testing a new drug or medical treatment to determine its effectiveness and safety for human use. After a new drug or treatment is developed, it must undergo clinical trials and pass certain requirements before being marketed.
In Vietnam, the field of clinical research is new but fast developing. We talked to Ms. Pham Thanh Hoa and Mr. Phan Minh Hai from Big Leap Research, a leading company in clinical research, about the potential as well as the challenges of conducting clinical trials in Vietnam.
Can you describe the process of conducting a clinical trial?
To conduct a clinical trial, the first step is to obtain authorization from the Ministry of Health. This means submitting a file with all the relevant scientific evidence and addressing all ethical concerns. After receiving authorization, we begin making necessary preparations such as setting up the study site, training researchers, and acquiring equipment. When all preparations are complete, we move on to the next stage, which is implementation. Doctors recruit subjects, administer the drug or treatment, and follow up, in compliance with the approved protocols such as good clinical practice (GCP) and local regulations. If a subject shows any adverse side effects, proper authorities must be notified immediately. Finally, the clinical trial data is collected and analyzed.
How long does this process usually take?
The length of a clinical trial really depends on the nature of the study. The first stage, which is where you get authorization and make preparations, usually takes about 6-7 months. This is longer than it takes in other countries because the process hasn’t been standardized in Vietnam, but recently the time has been shortened by new guidelines. The second stage, implementation, can last anywhere between 1-5 years, depending on the study design. Data analysis, which is the last stage, usually takes between 1-3 months.
Is it mandatory for pharmaceutical companies to conduct clinical trial for their drugs?
Most pharmaceutical companies in Vietnam don’t develop for themselves what we call “modern medicine.” Instead, they produce generic drugs. After the company that developed the drug expires its patent, other companies can use that formula to develop their own versions of the drug, called generics. The Vietnamese government requires generic drugs to undergo a bioequivalence test, to ensure that the generic drug is equivalent to the original drug. But if the original drug has been developed overseas, racial and ethnic differences suggest we should have data for Vietnamese people too.
How has clinical research developed in Vietnam? Is there a need for local clinical research companies such as Big Leap?
Before 2008, we applied international standards, the ICH-GCP. The Vietnamese government established the first Vietnam-specific set of regulations for clinical trials in 2008. These new regulations include circulars to instruct companies and doctors on clinical trial rules and procedures. Generally speaking, doctors were not trained on how to properly conduct clinical research, and would struggle to adhere to the strict and precise methods involved. They also tend to be overworked; they can’t dedicate themselves to the research project while simultaneously tending to their patients. That’s where clinical research companies come in, to assist doctors and ensure the trial goes smoothly.
At this time, international companies were also coming in to Vietnam. Their prices are very high, being global prices, but they use local human resources. So we came up with the idea of forming a local company, using local resources and international expertise. That’s how Big Leap Research was born.
How is Vietnam’s potential for clinical trial?
Vietnam is a good place to conduct clinical trials. There is a big patient pool. The costs are low. Our doctors have great expertise. They just don’t have the material and assistance to run adequate clinical trials. At Big Leap Research, we help doctors with the more technical tasks they’re not familiar with, such as processing data and working with authorities, so that they can focus on applying their expertise to the research.
What are some difficulties in conducting clinical trial in Vietnam?
Clinical research is a new field in Vietnam, so a big problem is the lack of awareness of what clinical research is and why it is important. There is very limited assistance from the Ministry of Health to ensure compliance with the law. Hospitals in Vietnam are unfamiliar with doing research: they lack the necessary material and facilities, and they tend to be wary about providing access to confidential patient information. This affects the amount of data that we are able to collect. Doctors might also make mistakes during the trial due to overworking and put the subjects at risk.
How do you see Big Leap Research moving forward?
Big Leap was founded on very simple premises: if other countries can succeed at clinical research, why can’t we? Clinical research in Vietnam is developing very quickly. Our goal is to make Big Leap Research the best clinical research company in Vietnam, even better than the global companies that have a presence here. Later on, we might expand overseas, to Laos or Cambodia — other countries that have not had a clear path for clinical research.
But most of all, we want to help Vietnamese pharmaceutical companies start developing their own drugs and gain the confidence of Vietnamese consumers. We often hear about how Japanese people absolutely trust and support their local products, but Vietnamese people don’t do the same. We hope that with the development and standardization of clinical research, we can finally affirm our brand in the market, both locally and globally.