Almost half of Ukraine’s clinical trials to find new therapies are still recruiting patients despite ongoing conflict, Phesi analysis shows

Date: 10. 14. 2022

Recruiting sites drop 48% in Ukraine and 52% in Russia, yet more than 2,500 trials still running in region

Boston, USA. 6 October, 2022: Phesi, a global provider of patient-centric data analytics, has today published its latest update on the significant impact of the war in Ukraine on clinical development in the region. Phesi’s analysis of recruiting investigator sites (those actively enrolling patients) finds that since the beginning of 2022 to the 1st Oct 2022, the number of recruiting sites has fallen from 1,814 to 940 (48%) in Ukraine, yet the other half are continuing to recruit. In Russia, recruiting sites have fallen from 3,412 to 1,638 (52%) and in Belarus from 84 to 33 (55%).

The data also show that neighboring Poland has increased the number of recruiting investigator sites by 10% from 3,473 to 3,829, indicating that Poland has been able to fill some of the gaps in clinical development caused by the war. In total across the four nations, there are 2,578 sites still actively recruiting patients (fig.1.).

“The drop in recruiting sites in Ukraine and in Russia sadly confirms our earlier prediction that the impact of war in the region on clinical development, and most importantly on patients, is considerable. However, what is heartening to see is that despite the terrible situation, there is still significant clinical trial activity taking place in the four countries that we have analyzed,” commented Dr Gen Li, CEO and Founder, Phesi. “This is hugely to the credit of clinical trial professionals and sponsors and speaks to their resilience. The global COVID-19 pandemic was unable to completely stop them and neither has the war. I congratulate our colleagues on maintaining such a high level of activity and working to minimize the impact on patients.”

Phesi’s original analysis issued in March 2022 highlighted that trends in the region mean some indications under investigation are set to be impacted more significantly. More than a quarter (26%) of all trials in Schizophrenia take place in Ukraine and Russia, as well as a high proportion of gastrointestinal disease studies – including Ulcerative Colitis (14%) and Crohn’s Disease (10%) (fig.2.). There are clearly ethical issues associated with suddenly discontinuing treatment and wider medicine availability at a time of crisis, and it’s clear that trial sponsors and personnel have worked hard to maintain a high level of activity despite supply chain and security challenges.

“It is encouraging to see that neighboring countries like Poland have increased their own study activity. The main priority in clinical development should always be patient centricity, so maintaining as much research as possible is critical to patients in the region,” continued Dr Li. “The war in Ukraine is moving fast and disruption will continue for some time. I urge trial sponsors to keep up their vital work and continue funding sites, even those that might be suspended, and maintain dialogue with regulators and CROs to ensure data integrity is maintained.”

The use of real-time predictive analytics solutions can help sponsors optimize site, country, and investigator selection to minimize the negative impact of events on cost and cycle time. Additionally, data may already exist in enough volume to close knowledge gaps – we can do this by using digital data from over 60 million patients globally to supplement studies and get trials over the line.

For more information on Phesi, visit: https://www.phesi.com.

Fig.1. Number of recruiting investigator sites from 1st Jan 2022 to 1st Oct 2022 (analysis conducted Oct 2022)

 

Fig.2. Percentage of sites in Ukraine and Russia taking place in selected diseases (analysis conducted March 2022)

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