Two years ago, with a group of bioethicists from the Yale University Bioethics program, I co-authored a white paper that talked about the ways we can facilitate Ukrainian refugees’ continued participation in clinical trials, which is often the only potential treatment option.
Two years ago many of our lives changed with the full scale invasion of Russia on Ukraine. Millions have been impacted. With the destruction and horrors of war, one of the big challenges was – and remains – maintaining healthcare access for patients. This includes clinical trials patients.
The problem continues
This paper is even more important now, as the problem has moved from being acute to chronic. Before 2022, Ukraine was a powerhouse for clinical trials in Europe. Almost 40% of those trials were in the cancer patient population. For many new trials, the beginning of the full scale war meant a delay or cancellations, and new trials dried up. Patients in Ukraine today have limited access to new trials, and they can’t afford to wait any longer.
Some of them have decided to relocate for treatment and continue to be clinical trials participants as refugees, but this presents a new challenge with the limited accessibility of cross-border clinical trials.
In recent months, I spoke with many clinical trials sites and site networks, especially in Ukraine’s neighbouring countries. They all indicated that they are eager to enroll clinical trials patients who arrived from Ukraine, potentially even with the support of Ukrainian physicians and nurses who also relocated.
Solution
What they lack is the necessary patient-facing materials in the Ukrainian language at the start of the study. A country specific informed consent document or any ePROs translated into Ukrainian is needed (like in the USA where it’s normal to encounter both English and Spanish versions of all materials).
Such a simple solution would make a difference in patients’ care and, in many cases, accelerate the enrolment process.
With patients’ mobility on the rise – not only due to war – this is just the tip of the iceberg of the needs of cross-border clinical trials and the industry’s need for adaptation. But that’s a whole other story – one we’ll get into next.