International Clinical Trials: how the war in Ukraine affects the Clinical Trial market and patients and what kind of amendments to legislation might be needed in the future
Natalia Denisova, MD, PhD
VP, Head of Medical Affairs, MphaR
Sara Frau, PhD
Scientific Communication Director Oncology
Jaroslav Streharski, MD
ISL Head, Europe
Until the beginning of 2022, it was difficult to imagine a situation to find ourselves amidst a war in Europe. However, February the 24th transformed the whole set-up we are accustomed to. Like every facet of life, war has disrupted the spirit of healthcare.
Ukraine has been a hub for International Clinical trials
For many years Ukraine has been one of the largest markets for international clinical trials. Ukraine was a sought-after location for international clinical trials with nearly 2500 public medical facilities and a competent healthcare system. Several other factors came into play behind Ukraine’s success as a clinical trial hub (1):
- A hefty pool of potential study subjects (large treatment-naïve population)
- The experienced population of GCP-trained clinicians
- Demonstrated high quality of obtained data and lower costs comparing other European countries
Virtually all Big-Pharma companies have been conducting trials in designated Ukrainian trial sites, and patients receive treatments as a part of these clinical trials.
A steady increase in the number of conducted clinical trials has been witnessed in Ukraine (2).
In the last five years, 2423 clinical trials have been operated in Ukraine—more than several Eastern European countries and even Western countries like Finland and Ireland (3).
Clinical trials: the current state
ClinicalTrials.gov has listed 662 clinical trials, which are at present active in Ukraine, covering critical diseases like cancer, multiple sclerosis, COVID-19, and others. Out of which 257 are active (not recruiting), 372 studies are still recruiting, 17 are enrolling by invitation, and 16 trials are not yet recruiting (4).
The majority (56%) of trials are still recruiting, and they are getting the fatal blow of a disrupted recruitment process during the war. The “active, but not recruiting” trials would be equally affected as the follow-up course will likely cease.
Patients are suffering the most
Comprehending the present situation in Ukraine, together with all crises, we realize that thousands of patients associated with international clinical trials are now left without any support. Logistical hurdles are causing delivery of drugs next to impossible, unsettling continuous medical support, and preventing potential relocation of patients to another country to continue their treatment within the frame of the clinical trial(s). The larger proportions of the patients associated with the clinical trials have this opportunity as a last resort to treat aggressive diseases like cancer. Treatment disruptions would result in life-threatening consequences or even death.
How can we support the patients?
What we learned over the past few weeks was that patients being part of international clinical trials are in urgent need of support in 3 key areas:
- 24/7 hotlines where patients might report any issue – similar to the 24/7 hotline set up by the Ukrainian Ministry of Health (initially launched for COVID-19 support)
- Access to investigational products – which is essential for the continued health and well-being of the trial participants. With the interrupted logistics, it is presently challenging to distribute the investigational products to different locations in Ukraine.
- Access to Healthcare and hospitals – with disarrayed healthcare, the patients are not receiving adequate support.
Legislation might need a tweak in the future
Many patients who are part of International clinical trials receive life-saving treatments. Relocation is urgently required to maintain their treatment. Although hard to believe, the reality is opposing the need — current legislation in Europe and other countries prohibits relocating patients to other clinical sites or a different country to continue their treatment pertaining to the same clinical trial.
The legislation on the relocation of patients would require adjustments, especially in the face of war — and this might be the only way out for the patients.
Support from Global Pharma
In parallel, Global Pharma companies and CROs functioning in different countries might adjust the standard procedures, electronic databases, and protocols to simplify patient inclusion in International Clinical Trials for potential cross-country relocation, maintaining their participation in the trials.
- Running a Clinical Trial in Ukraine [online] https://www.biomapas.com/running-a-clinical-trial-in-ukraine/ (Accessed March 28, 2022)
- Clinical trials in Ukraine [online] https://corex-logistics.com/news/klinicheskie-issledovaniya-v-ukraine-razvivayushchiysya-rynok/ (Accessed March 28, 2022)
- Number of clinical trials by year, country, region and income group [online] https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/number-of-clinical-trials-by-year-country-who-region-and-income-group (Accessed March 28, 2022)
- Search of: Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | Ukraine – List Results – ClinicalTrials.gov [online] https://clinicaltrials.gov/ct2/results?cntry=UA&Search=Apply&recrs=b&recrs=a&recrs=f&recrs=d&age_v=&gndr=&type=&rslt= (Accessed March 29, 2022)