A Hidden Cost of War in Ukraine: Clinical Trials and New Medicines

The war in Ukraine continues to threaten the safety of clinical trial patients and healthcare providers, with serious consequences on the health and wellbeing of people and families. On International Clinical Trials Day, we talk about the impact on both people and scientific progress with Lionel Bascles, Global Head of Clinical Sciences and Operations, and Megan Heath, CSU Region Head and global clinical task force lead at Sanofi.

Applied Clinical Trials: How does the war in Ukraine affect research into new medicines?

Lionel Bascles: War affects every aspect of a person’s life. That includes healthcare. Can you imagine what it’s like to need care, to depend on continued treatment during an armed conflict? It also includes things like participating in a clinical trial. And it adds up: every person who participates in a clinical trial contributes to scientific progress, whether they’re a patient or healthcare provider, someone who provides support in the clinic, or one of the many, many people who keep the supply of medicines moving. If you lose any one of them, the effects can be far-reaching, maybe more than you realize. It can’t be said enough: without the people who participate in clinical trials, without volunteers and clinicians, there simply would be no new medicines. No new vaccines.

This crisis has made us redouble our efforts: it’s our duty to be there for those working at our clinical sites and the patients they care for. We must do whatever it takes to mitigate the effects of disruption, because it is unacceptable for our patients, and for science, to become just so much collateral damage.

Moving hospital equipment and furniture underground in Ukraine, March 2022. Photo courtesy of Roman Fishchuk.

ACT: How have your teams been adapting to keep clinical trials going?

Megan Heath: So, I am part of a task force that works closely with the local Ukraine team, who have been incredibly resourceful and adaptive. From the start of the conflict, our teams have been working closely with people who have a vast store of on-the-ground knowledge. As you might imagine, each of them is adapting continually to a changing situation. Quite often, they’re going to extraordinary lengths to help patients and investigators. They’ve been coming together to solve problems like getting medicines across borders and through cities, or getting supplies to study sites, or helping migrating patients stay on their protocols, and keeping investigators connected to their patients.

Lionel: Megan’s task force has been working night and day to coordinate and provide support, because if any one of those steps fails, the patient’s own health may be impacted. I am convinced that all our efforts are a source of hope. Personally, I would never want to lose the trust of anyone involved in our trials.

ACT: What makes it so challenging? Can’t a lot of clinical trials happen remotely, with telemedicine?

Lionel: We learned some valuable lessons in the early days of the pandemic about being flexible and pivoting quickly. We’re laser focused on keeping all our patients in their studies and to give them some continuity, and we know that demands a lot of flexibility, ingenuity, and patience.

The Ukrainian authorities also built on lessons learned in 2020: very soon after war broke out on February 24th, they issued guidance to help maintain clinical trials. But the disruption is unpredictable. We need to constantly secure new routes, new carriers, new approaches to supply sites, new ways to ensure patients can access their treatments. Our studies rely on consistent, periodic assessments that need to be performed in hospitals – but those hospitals are in cities that have become fully militarized, where doing things like running a routine MRI are out of the question.

ACT: How have you been able to mobilize to keep up with things like displacement, patients migrating, supplies not being available?

Megan: When the situation started to escalate, our Global Security team worked with us locally to prepare for military impacts, including migration. Millions of people in Ukraine have been displaced, including our patients—people who have volunteered to participate in a clinical trial at one of over 100 sites.

Since then, we’ve been working with people who bring a lot of different specialties to the table, all trying to figure out what our patients and investigators need from one day to the next, and how we can support them.

ACT: Can you give me an example of how you have helped a patient?

Megan: One thing that stands out to me is the first of our patients who migrated out of Ukraine to an EU country. As a sponsor, we never know who exactly the patients are, but we need to make things happen for them. With migration, there are so many questions to sort out. The study was not running in the sanctuary country and hadn’t been approved by the health authorities there—could we talk with them? There was no supervising doctor to administer treatment and do assessments—could we find someone qualified? The assessment required special equipment—could we find it? The patient had built a strong relationship with their investigator in Ukraine—could we help the two doctors communicate?

ACT: Did you manage it?

Megan: As Lionel said, we’d been tested by the pandemic, so we knew we could do it. Our mindset is to focus completely on the task at hand—just fix the problem in front of us, right now–and adapt to change as the constant. Importantly, our legal, medical, insurance, supplies and clinical teams were prepared to swing into action to make the right connections.

And the solidarity around Ukraine helped. The health authorities understood they needed to act quickly and worked closely with our regulatory team to find solutions. It’s thanks to their guidance and approval that the patient is still on their trial. Other countries have followed suit, keeping patients treated, protocols observed, and science moving forward whenever possible.

ACT: Are things working out like this for other patients who have been displaced?

Megan: It’s not always possible to keep patients on their trial, to keep doctors connected. But we’re doing everything we can to facilitate that. In Ukraine, where many patients have migrated within the country, the partnership of local teams has been humbling.

Roman Fishchuk, Olesya Gerych, and Kuziuk Mykhailo, colleagues working on clinical trials in Ukraine. Photo taken at the Central Municipal Hospital #1 in Ivano-Frankivsk, March 2022. Photo courtesy ofIvanna Kirieieva.

ACT: What have they been doing?

Megan: Well, for example, our warehouse staff worked night and day to move medicines from a high-risk warehouse into a safer place while still maintaining the cold chain. Our distributors have been working closely with us so we can get drugs from Montpellier, France to Ukraine when air transport isn’t possible and roads and couriers are blocked. And when it became too dangerous or impossible to supply study drug kits to some locations, we successfully explored how to extend their shelf-life.

Behind the scenes, at all hours of the day, a lot of people have been working together to make things happen. That’s supply chain innovation.

ACT: Communication is a big challenge—what kind of support are you providing?

Lionel: We are there for patients, to treat them wherever they are, wherever they’re from, however we can. I’m proud of how quickly our medical information teams set up a global hotline run by a Ukrainian-speaking team. They learned how to manage calls from Ukraine study participants and investigators as they move, and how to coordinate activities with service providers in many different countries. Patients anywhere in the world can reach out and get a response from medical professionals—and it makes a difference.

ACT: What are you taking away from this experience?

Megan: Every day, we strive to bring science to the patient—and I think that has happened. For these patients, clinical research was part of their healthcare journey. It wasn’t something extra—they saw this as their miracle. That has made a deep impression on everyone, I think, and really solidified our commitment.

Lionel: We are not the only company whose development of new medicines and vaccines will be impacted by this conflict. Like many others, we will see delays in scientific advancement that reverberate throughout society. On International Clinical Trials Day, I’d like to recognize the dedication and resilience of those who contribute to science in the face of adversity and, on behalf of everyone in our team, express our deepest hope for a return to peace.