Russia’s invasion of Ukraine is causing what the Financial Times called a “many-sided economic shock,” sending global prices sky-high for goods ranging from fuel to fertilizer. While the consumer-facing economic impact is undeniable, the war in Ukraine is also taking a toll on a less visible sector: the clinical research industry. Per the U.S. Food and Drug Administration’s clinical trial database, there are over 250 active trials with research sites based in Ukraine. The unfortunate truth is that the violence and mass displacement occurring across Ukraine will have lasting implications for the clinical research industry.
How Much Clinical Research Is Based in Ukraine?
To understand the war’s impact on the clinical research industry, it is vital to consider the sheer number of clinical trials with active research sites based in Ukraine. Outsourcing-Pharma, a publication dedicated to clinical trial news, cites clinical tech services company Phesi, which recently released a report shedding light on this issue. The Phesi report examines “pivotal” trials sponsored by pharmaceutical companies – trials that Outsourcing-Pharma reporters say represent “the most critical global clinical development activities.” According to the Phesi report, about 4.4 percent of recruiting investigator sites were based in Ukraine and Russia – most of which are now on hold or canceled entirely. These sites are involved in some of the most cutting-edge studies occurring in the clinical research sector. For example, per the Phesi report, more than a quarter of all trials in schizophrenia currently take place in Ukraine and Russia.
How Is the War in Ukraine Impacting the Clinical Research Industry?
The ongoing unrest in Ukraine has forced trial sponsors to halt the vast majority of trials in the interest of protecting trial volunteers and healthcare providers. The big question: how long will trial sponsors have to wait to resume trials? Gen Li, the CEO and founder of Phesi, spoke with Outsourcing-Pharma about the short-term and long-term impact. “In the short term, it would be unlikely for trials in Ukraine to get back up and running quickly given the other understandable priorities that the country will have,” Li said, adding that the war’s long-term effects may go far beyond Ukraine’s borders. “Whilst the war is happening in a single country, the impact for the clinical development industry will be global and long-lasting; coming on top of the pandemic and with many countries still implementing lockdowns, it’s an increasingly difficult time for pharmaceutical companies.”
Interestingly, the Phesi report indicates that the disruption from the conflict in Ukraine will vary from sponsor to sponsor, likely impacting companies with global development strategies. Those companies include Eli Lilly, which centers around eight percent of its trial sites in Ukraine and Russia.
Can the Industry Overcome the Setback?
Leaders in the clinical research industry are clearly eager to overcome the disruption posed by the Russian invasion of Ukraine. Remote and virtual studies are a key part of that strategy. Experts like Paul Chew, Phesi’s chief medical officer, are also encouraging sponsors to continue to fund research sites – even sites that are currently suspended in Russia and Ukraine. Continual funding will allow trial operators to maintain data integrity; it may also allow researchers to use existing and synthetic data to “get trials over the line” and deliver important treatments to patients in need.
While the war in Ukraine poses obvious threats to the clinical research sector, one thing is clear: Evolving technology – and a continued focus on data integrity and medical innovation – will carry the industry through this global crisis.
QPS is a GLP- and GCP-compliant contract research organization (CRO) delivering the highest grade of discovery, preclinical and clinical drug research development services. Since 1995, it has grown from a tiny bioanalysis shop to a full-service CRO with 1,100+ employees in the U.S., Europe and Asia. Today, QPS offers expanded pharmaceutical contract R&D services with special expertise in neuropharmacology, DMPK, toxicology, bioanalysis, translational medicine and clinical development. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. Through continual enhancements in capacities and resources, QPS stands tall in its commitment to delivering superior quality, skilled performance and trusted service to its valued customers. For more information, visit www.qps.com or email [email protected].