The pros and cons of conducting clinical trials in Ukraine
More than 500 clinical trials are currently being performed in Ukraine. For comparison, approximately 1,200 are being conducted in neighboring Poland and 14,000 in the US.
Here are some more numbers. On average, only 4 out of every 100,000 residents of Ukraine participate in clinical trials. In Poland the figure is 15, Germany – 21, US – 40, Switzerland – 70.
One, but by far not the only reason why Ukraine lags behind in this area is the public misconception of clinical trials stemming from the myth that “foreign pharmaceutical companies are experimenting on Ukrainians.” Meaning, they’re doing something unethical and unacceptable for a modern, developed society.
Similar objections can be heard from ordinary people, who have little idea of how drugs make it to pharmacy shelves. Sometimes even populist politicians try to appeal to voters by claiming that Ukraine is a testing ground for foreign interests.
Besides these myths, there are also objective barriers to the development of clinical research in Ukraine. Even so, the clinical trials market does have its advantages.
A year ago, a group of research doctors and others working in the field established the Ukrainian Association for Clinical Research NGO. The organization’s mission is to protect the rights of research doctors and to promote the development of clinical research in Ukraine. Their goal is to double the number of clinical trials in Ukraine over the next 5 years.
One of the co-founders, Dr. Ivan Vyshnyvetskyy, became its director. Until 2014, he was practicing medicine in Donetsk while also conducting clinical trials. But when war broke out in East Ukraine, he was forced to move to Kyiv and start a life anew.
Today Dr. Vyshnyvetskyy teaches at the Bogomolets National Medical University in Kyiv and also manages the Research Center at Zhytomyr City Hospital #1, west of Kyiv. He and his colleagues there conduct clinical trials. This has now become his primary job.
According to his rough estimates, there are 3,500 research doctors in Ukraine, 350 of whom joined the NGO. “Another 2,000 support us, but so far are in no rush to pay membership dues,” Mr. Vyshnyvetskyy says half-jokingly.
We asked Dr. Vyshnyvetskyy to describe the peculiarities of the Ukrainian clinical trials market.
- There are several reasons why so few clinical trials are being conducted in Ukraine. One of the reasons is that our regulatory bodies take a long time to decide whether or not to allow a clinical trial to take place. And for the sponsor (the pharmaceutical company ordering the program) every day spent waiting is very expensive.
Other difficulties are due to systemic factors. It’s unfortunate, but we must admit that Ukrainian doctors often don’t practice medicine in the exact same way as their foreign colleagues. And not many of them are fluent in English, without which it’s nearly impossible to conduct clinical trials.
Our infrastructure is also not the best, to say the least. For example, not every hospital has a CT or MRI machine, which are necessary for certain studies. This means that the hospital can’t take part in some programs.
And another point. Clinical trials involve patients with complex, severe and often incurable diseases, when all options for traditional treatment have been exhausted. Due to limited healthcare resources in Ukraine, many patients don’t even receive standard treatment, and if that’s the case they won’t get into clinical trial programs.
- Another factor stopping international sponsors from coming to Ukraine is the quality of data in certain indicators that sometimes comes from Ukrainian research centers. Let me give you an example. There is some difference between the understanding of asthma in the post-soviet space, including Ukraine, and the rest of the world. We have a different interpretation of what’s considered an asthma exacerbation. Now imagine that a sponsor orders a trial of a drug to prevent asthma exacerbation. The statistics they get from Ukraine may differ from the statistics in other countries where the drug is being tested. So next time the sponsor may not be willing to do a similar study in Ukraine.
Still, those are only specific situations, and in general, Ukrainian clinical research sites demonstrate good quality of processes and data generated.
- But the Ukrainian clinical trials market does have its competitive advantages. One of the main ones is the high speed of recruitment of clinical trial participants. This is the initial stage of a trial, when people who meet certain criteria are selected. This is a difficult process that takes a long time, and again, is expensive for the customer.
In Ukraine participants are recruited quickly, although we researchers have to make every effort to explain all the conditions, risks and benefits to the patients and their families and dispel unjustified doubts. People usually agree to participate because for them this is a real chance to get free innovative and quality treatment in Ukraine. But when it comes to the absolute number of people participating in trails, there aren’t many, because there are few trials and few research centers.
Another advantage is motivated researchers. After all, conducting clinical trials in Ukraine is perhaps the best way for a doctor to legally earn a decent living. Even working in a private clinic can’t compare, let alone the salary at a state medical institution.
We are regularly inspected by representatives of foreign regulators, such as the Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA), and even the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and they find no more violations (even fewer) than in countries that have been doing clinical trials much longer and in greater numbers.
- There is no shortened or simplified procedure for clinical trials in Ukraine. It is also impossible to conduct a trial by circumventing the law. When someone says that a trial of a drug can be started very quickly, that’s not so. What’s faster is the recruitment of participants and this really can tip the scales in favor of Ukraine when choosing countries to test a new drug.
Phase I and II of a clinical trial can be conducted in a single country and that’s normal. But in Ukraine these type of trials are rarely done because they require specifically equipped medical centers, which are few and far between. Phase III and IV are most common in Ukraine.
Many western pharmaceutical companies have to test their drugs in different countries. First, to prove that the drug works on different populations. Second, to allow them to register the drug in each of these countries. By the way, this is one of the tools that allows countries to attract more trials. China, for example, doesn’t allow a drug to be registered unless it’s been tested in China. This is a huge market, so obviously pharmaceutical companies accept these terms.
- The war did not significantly affect the clinical trials market. There was a pause, but when it became clear that the fighting was localized in the East, business resumed as normal. Today I’m seeing signs that the market is slowly growing. New clinical research organizations (CRO) are appearing. They are the intermediaries between the customers, who delegate most of the functions to them, and the research doctors directly performing the studies. New services that didn’t exist before on the market are being introduced, such as transporting clinical trial participants between their homes and the hospital. It is also becoming easier to send biological samples abroad for analysis. But there is still much untapped potential in this field.
Author: Dmytro Simonov (Translation by USUF)