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The Current State of Clinical Trials in Ukraine—A Conversation with Dr. Roman Fishchuk

The Current State of Clinical Trials in Ukraine—A Conversation with Dr. Roman Fishchuk

Meet Dr. Roman Fishchuk, an esteemed otorhinolaryngologist (ENT) whose journey in the healthcare field has been marked by a commitment to providing medical care and innovative treatment options through clinical trials in his native Ukraine.

Having graduated from Ivano-Frankivsk National Medical University, Dr. Fishchuk specialized in otolaryngology and completed a Master’s degree at the University College London Ear Institute.

The CRIO team is fortunate to have Dr. Fishchuk as a valued partner. After our initial connection at an industry conference, we have established a close working relationship with Dr. Fishchuk, providing technology to support the execution of clinical trials in Ukraine.

What is the current landscape of clinical trials in Ukraine? How has it changed over the past few years?

Clinical trials in Ukraine faced a downturn due to the ongoing conflict with Russia. Unfortunately, most sponsors and CROs haven’t resumed their operations in Ukraine. Prior to the conflict, Ukraine approved approximately 200 new international clinical trials annually. The war has caused a significant decrease in the number of trials, but Ukrainian sites continue to perform well. Sites in Ukraine adapted well to the challenges posed by both war with Russia and the COVID-19 pandemic, by incorporating various components of decentralized tools.

What challenges do you face conducting clinical trials in Ukraine?

The major challenge is the lack of clinical trials in Ukraine, leading to many other challenges —loss of colleagues due to financial constraints, site closures, patient relocation, and communication gaps with CRAs.

What is one thing you wish the industry knew about conducting trials in Ukraine?

The critical message is that Ukrainian patients, doctors, and the healthcare system need clinical trials now more than ever. Despite the adversities, Ukraine remains a strong candidate for clinical trials, with a strong recruitment potential, and we want to be involved.

In what ways do clinical trials benefit your local communities and patients?

Clinical trials offer various advantages to both our patients and the healthcare system. Firstly, clinical trial patients have access to the most innovative treatment options. Even when a placebo is involved, patients receive background therapy depending on their condition. Another benefit for patients is the reduced waiting times for medical appointments since clinical trials require procedures to be completed according to a predetermined schedule.

These advantages contribute to significant cost and resource savings for the Ukrainian healthcare system, as the expenses are covered by the sponsor of the clinical trial. Additionally, healthcare facilities and personnel receive compensation for the time and effort dedicated to the research trial. Overall, these factors create a mutually beneficial scenario for patients, the healthcare system, and the researchers.

Can you share any success stories of how clinical trials have directly impacted the lives of patients?

Our goal is to conduct clinical trials that positively impact patients’ lives, steering clear of trials that will not improve their condition or quality of life. As an example, our patients gained early access to antiviral medications for COVID-19 through clinical trials, a year before commercial availability. Additionally, our patients have received access to treatments across a wide variety of conditions—nasal polyps, asthma, COPD, diabetes, rheumatoid arthritis, stroke, multiple sclerosis, and others—that would otherwise be unavailable to them.

In your own opinion, why is it important for pharmaceutical sponsors to conduct clinical trials in Ukraine?

Conducting clinical trials in Ukraine is very beneficial for both sponsors and CROs. Due to the unfortunate circumstances, Ukraine has access to a unique patient population, unavailable in other parts of the world. Financial considerations also play a significant role, as Ukraine has traditionally been an attractive country in terms of budgeting and regulatory timelines.

By recommencing clinical trials in Ukraine, companies can express their solidarity with our patients and healthcare professionals. For some patients, participating in a clinical trial is a matter of life and death. The ongoing war places an enormous financial burden on the country, making clinical trials a valuable means for the healthcare system to secure additional sources of income.

What benefits do you see in employing technology for the execution of global clinical trials?

Technology helps improve processes across different industries, and the clinical research sector is no exception. However, technology should be used with careful consideration to ensure the focus is on making lives easier for the end-users. To ensure efficient utilization, involving potential end-users in the early stages of product development and testing is crucial.

In the context of the clinical trial industry, the benefits of technology include but are not limited to—improved access to clinical trials for various patient populations, enhanced protocol compliance due to flexibility in procedure and visit structure, more accurate data, remote access to the information, among others.

Looking ahead: What do you hope Ukraine’s role in clinical trials will look like in the future?

I envision Ukraine becoming a top destination for sponsors and CROs. Like any location globally, there are both advantages and disadvantages to consider. While I acknowledge that there might have been certain heightened risks compared to other countries, it’s important to note that these concerns have mostly been resolved. We are open for communication regarding the technical details related to clinical trial execution in Ukraine.

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