Ministry of Health – Status of Clinical Trials in Ukraine 2022
The Ministry of Health’s State Expert Center conventionally shares information about the progress of clinical trials (CTs) in Ukraine. The information is compiled by the Department of Expert Evaluation of Preclinical and Clinical Trial Materials and the Office for Laboratory and Clinical Practice (GLP, GCP) Audit. However, in 2022, Russia’s military offensive had a significant impact on the planning and execution of clinical trials for medicines in Ukraine.
In their latest report, the Ministry of Health provides an objective update on the status of clinical trials in Ukraine. It is different from the usual presentation of data and primarily focuses on the changes that occurred in the field of CTs in Ukraine in 2022, which includes the ten months during the war.
In this article, we have a look at the key takeaways from the report.
Senior Key Account Manager
Clinical Trials Communication
- The Department processed a total of 4,939 incoming letters in 2022, including referrals for clinical trials and various CT-related letters.
- The Department received 132 letters regarding the premature termination of clinical trials in Ukraine, with 108 due to the war and 24 due to other reasons such as financial, safety, and efficacy issues.
- The Department processed 223 letters from Sponsors/CROs regarding the transfer of study subjects to other clinical trial sites, both in Ukraine and abroad, with most transferred patients being in the therapeutic areas of oncology, neurology, rheumatology, gastroenterology, and cardiology.
Clinical Trial Approvals
- 68 new clinical trial sites (CTSs) were approved in 2022, which corresponded to 68 new ethics commissions at healthcare settings.
- There have been positive trends in clinical trials in Ukraine, with 63 trials starting and 9 resuming during the reporting period.
- 18 CTs resumed enrolment of patients
The Department maintains regular contact with applicants to ensure the proper conduct of CTs under the conditions of martial law.
Clinical Trial Audits (CAs)
- In 2022, 28 CAs were conducted, including 11 clinical trial audits on compliance with regulatory requirements during the transfer of study subjects in clinical trials.
- Among the 28 CAs, 12 had no remarks, 10 had minor remarks, 4 had significant remarks, and 2 had critical remarks.
- Only 1 case of minor deficiencies was identified during the CA regarding compliance with regulatory requirements during the transfer of study subjects in clinical trials, and the other 10 CAs revealed no violations of regulatory requirements.
A fuller report with statistics and graphics can be read on the dec.gov.ua website.
In summary, it can be stated that clinical trials in Ukraine are being conducted with due compliance to the existing regulatory framework, which conforms to international standards and ethical principles in adherence to the principles of GCP. It is worth noting that the duration for the examination of clinical trial documents and materials has recently been reduced to a period of 30 days.
Additionally, it can be observed that the logistics system has adeptly adapted to the current circumstances, and the timing for importing and delivering IMP\CTS to clinical sites remains the same as before the war.
The clinical sites, researchers, and patients are all well-prepared and eager to participate in CT.
In light of the above observations, one may pose the rhetorical question, what are we all waiting for to initiate clinical trials in Ukraine?
Clinical Trials Logistics in Ukraine
If you are considering Ukraine as a destination for your next clinical trial, Oximio can provide a complete, end-to-end supply chain solution with a dedicated project manager:
- Clinical Trials Logistics
- Sourcing for Clinical Trials
- Patient Focused Services
- Adaptive Logistics for Advanced Therapy
- Services in Ukraine
To talk to a member of our team please contact us. We’d welcome the opportunity to discuss your clinical research and guide you through the process.