Ukraine is currently experiencing difficult times due to an unprovoked act of aggression from a neighbor. As a country with 40 million+ inhabitants, it has tremendous potential for international clinical research. The clinical research infrastructure, well-educated and clinically experienced investigators as well as firm regulatory policies together with young and IT-committed generations should constitute a solid base to build upon for the International Clinical Research Society.

General

Ukraine is an economically developing country. The potential of Ukraine as a location for clinical trials has not yet been fully explored. The location in Eastern Europe, population, and political and economic development of Ukraine could provide a volume of clinical trials in the country comparable to Poland. In the period 2010- 2020, this was facilitated by such factors as:

doctor’s and scientist’s interest in the field of clinical research

– support by Government line ministries and local executives

– integration development with EU

– positive experience by patients participating in clinical trials

– an emerging positive image of clinical trials in the general Population

Patients were recruited quickly, study protocol procedures were adhered to, and deviation rates were minimal due to the investigators’ high qualifications and interest in the research work. Therefore, the impact of clinical trials in Ukraine has been significant and is rising.

Patients

Patients suffered the most when the conflict began. Those who remained in the territory involved in the conflict lost the opportunity to continue treatment or receive it by participating in new studies. Those patients who were forced to change their place of residence often lost the opportunity to participate in studies because they did not have access to physicians with similar experience and expertise in clinical trials as their previous treating physicians. In addition, a radical change of residence most often involves a deterioration in the quality of life, which affects overall health and the ability to receive treatment. Expensive treatment for many therapeutic indications has become practically inaccessible to people since, with the outbreak of war, the financial situation of Ukraine citizens has deteriorated significantly. For many patients, participation in a clinical trial is a chance for a cure, as well as free ongoing health monitoring. This is the reason for the high recruitment of patients and their desire to participate in the study. Both men and women of different ages are willing to participate in the research, depending on the nosology of the study.

Investigators

Since the military conflict in 2014 stabilised quickly and territorially affected only a small part of the country, there was an internal migration of the population. Many Investigators changed their place of residence when the conflict in Crimea started in 2014 and moved to regions where they were able to continue to engage in medical and research activities. These Investigators lost their patient bases but were able to bring their experience and knowledge to those regions and clinics where clinical trials had not been conducted previously. Principal Investigators assembled new teams and trained new specialists. Thus, such forced internal migration of specialists made it possible to increase the number of research centers and cover new territories of the country. All doctors taking part in clinical trials are not GCP certified, but according to the legislation they are obliged to have a local GCP certificate, issued by the MOH. According to Ukrainian legislation, any clinic has the right to participate in clinical trials, if they comply with MOH requirements (license, accreditation, local ethics committee).

Sponsors

During the conflict, many Sponsors moved their studies to other regions of Ukraine and have thus been able to continue study activities with few significant losses, since it remained possible to save the data and results obtained. The number of new studies, especially long-term ones, has now declined significantly since 2014.