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Industry must take steps in preserving data for use after the war.
The field of clinical trials in Ukraine is currently suffering significant losses, as well as any other area of economic activity. Hundreds of clinical trials have been disrupted. And how quickly we protect our potential and reputation as a reliable partner depends on how quickly the industry recovers and at what pace it will develop in the future.
The Russian invasion of Ukraine has left pharmaceutical companies wondering how to secure data and ensure that patients participating in clinical trials can receive the study drug while millions of people seek refuge from the bombing and flee to neighboring countries. But, according to research company GlobalData, 502 trials are underway in Ukraine.
Pharmaceutical companies often conduct multicenter clinical trials in many countries. Ukraine is in demand due to the large number of patients and the lower cost of doing business compared to the United States and Western Europe.
Nowadays sponsors, contract research organizations, and logistics companies are working hard to save the industry. Each sponsor provides their own recommendations and algorithms that cannot always be implemented. But everyone understands the situation and is united in their desire to maintain contact with patients. New ways to deliver the studied drugs and research materials are being actively sought. Possible solutions for sending biosamples are considered. Procedures for transferring patients from the most affected areas to safer ones and abroad are being worked out.
All investigators continue to do their utmost to perform their duties in accordance with good clinical practice (GCP) principles and the law. It is important to stay in touch with the patients, collect information about where they are. Inform them about the possibility of temporary or permanent transfer to other research centers to continue participating. Some patients are at risk of losing their last chance at survival.
It is necessary to take care of the safety of preservation of the research drug as a whole. Prepare the opportunity to evacuate primary documentation or transfer the necessary copies of documents to research centers where patients are transferred. Investigators should make every effort to help sponsors maintain clinical data and ensure that their quality is as high as possible. All investigators today are in different conditions and with different opportunities. But everything must be done for the preservation and development of the industry after the war.
Oleksii Korzh – Professor, MD, PhD, Doctor of Medical Science, Head of Department of General Practice – Family Medicine, Kharkiv Medical Academy of Postgraduate Education, Ukraine, a member of WONCA, RCGP, AAFP