Clinical Trials in Ukraine:
Lessons Learned from COVID

Extracted from The Global Impact of War in Ukraine on Clinical Research, April 2022 as part of our Clinical Research Cohort programming.

By Dylan Lasky

Westchester Biotech Project Clinical Research Cohort
Co-Chairs:
Ellen Bedenko, RN, CCRC,
Clinical Research Professional
Daria Crean, RN, BSN, Clinical Site Liaison, Medical Sciences

Medical investigators have to decide between pulling experimental drugs from people who desperately need them, and forcing patients to continue with clinical trials in a country where present trial sites could be bomb targets.”
— Svetlana Gramatyuk, Medical Director, Biobank Association of Ukraine

The invasion of Ukraine is impacting 400+ clinical research programs, critically disrupting essential, ongoing work. In April, 2022 we were updated on the current and shifting research environment. Going forward, we will be convening thought leaders to help address existing issues and prepare for disasters which may occur anywhere throughout the globe.

President of Ukrainian Association of Biobank, Svetlana Gramatyuk, describes the global impact of the War in Ukraine on clinical research and biobanking:

Clinical care and research have been affected by a decrease in trial capacity, in-kind support, and patients seeking personal care. Biobanks and biomedical research have been affected by a decrease in funding, facility access, and equipment maintenance. Gramatyuk explains that “medical investigators have to decide between pulling experimental drugs from people who desperately need them and forcing patients to continue with clinical trials in a country where present trial sites could be bomb targets.”

Currently, the main problem is the logistics of shipping biosamples out of Ukraine and shipping investigational medical products into Ukraine. To secure valuable samples, the Ukraine Association of Biobanks team has successfully transported all biological materials from the biobank in Kharkiv to a secure location. They packed up part of the collection on an emergency basis when the bombing raids started and were lucky not to have been hit. The association continues to support individuals who are escaping to surrounding countries so they can receive their treatment and participate as well. They had to pack up part of the collection  

Anshuman Sharma, Head of Product at Biofourmis, explains how the company applies lessons learned from the COVID-19 pandemic to the reality of the war in Ukraine.

Biofourmis was instrumental in supporting clinical trials in areas affected by COVID and allowing for the patients to continue their participation in clinical research. The company provides remote patient monitoring and decentralized clinical trial support in inpatient or outpatient settings. “As we learned in COVID times,” he says, “these have been approved by both central and local IRBs (Institution Review Boards).”

Ellen Bedenko, Co-Chair of Westchester Biotech Project Clinical Research Cohort, came to the United States from Ukraine years ago and is an RN in Philadelphia. She has actively volunteered with Ukraine relief organizations since 2014.

Razom is a nonprofit organization made up of 60,000 donors and volunteers. Razom means “together” in Ukrainian and serves as a constant reminder of the community that it takes to create, build and do. Razom creates spaces where people meet, partner and work together to unlock the potential of Ukraine. Upon the Russian invasion, the nonprofit quickly mobilized an emergency response, delivering humanitarian aid and critical medical equipment and supplies.
RAZOM for Ukraine:  https://razomforukraine.org/ 

Ilya Knizhnik, IT Project Manager at Penn Neurosurgery, is a Ukraine TrustChain co-founder. The organization has evacuated over 26,000 individuals from Ukrainian war zones, small villages, and orphanages. Knizhnik explains, “TrustChain has been successful in evacuating individuals for an average cost of the price of a large Starbucks latte, about $5 and feeds over 5,500 individuals daily.” One of the organization’s refugee centers is in Dnipro, and serves 350 people. It was built in 36 hours, including electrical and plumbing access. Ukraine TrustChain: https://www.ukrainetrustchain.org/

What’s Next

Ellen Bedenko is leading a working group to respond to these challenges and help set up coordination for clinical trials during times of upheaval anywhere in the world. To participate, contact Denise Albitz, Research Platform Director, at: research@westchesterbiotechproject.org

Westchester Biotech Project is a New York based, 501 (c) 3 nonprofit organization focused on cross border initiatives that stimulate collaboration among researchers, data scientists, engineers, sponsors, healthcare providers and patients. Back to Home Page