The war in Ukraine is causing disruptions in the conduct and planning of clinical trials. Although these disruptions are most severe in Ukraine, other countries are also affected, for example due to the arrival of refugees fleeing Ukraine or the impact of imposed sanctions.
This forces clinical trial sponsors to adapt the way clinical trials are conducted in the region. Adaptations are also necessary to protect the rights and safety of participants, including the continuation of ongoing treatment, as well as to preserve the quality of the data generated by the trials.
Although in the EU, clinical trials are authorised and supervised at national level, the EMA plays a key role in ensuring that Good Clinical Practice (GCP) standards are applied throughout the European Economic Area (EEA) in cooperation with the Member States.
The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published guidance for sponsors on how to manage the conduct of clinical trials in this war situation.
➡ Sponsors can adapt the way they conduct clinical trials affected by the war in Ukraine based on the experience gained during the COVID-19 pandemic.
➡ Priority should be given to the interests of patients already enrolled in the trial while considering the future conduct and feasibility of the trial from an ethical, medical and methodological perspective.
➡ It is recommended that scientific advice be sought early in the process if substantial changes to the current protocol and/or trial design are deemed necessary.
Scientific advice on methodological aspects and the impact of using the results of affected studies for regulatory purposes may be provided by the EMA or national competent authorities.
Substantial changes in the design and conduct of a trial must:
👉 be appropriately documented
👉 comply with local regulations
👉 be approved by ethics committees and the relevant competent authority
unless imposed by the need to ensure the safety of the participants and staff concerned.
Urgent safety measures do not require prior notification.
Nevertheless, the sponsor is expected to provide, as soon as possible, adequate information on the cause, the measures taken and the plan for future action, in accordance with Article 3.9 of CT-1 or Article 54 of the Clinical Trial Regulations (CTR).
Sponsors should use the estimation framework described in ICH E9 (R1) to address war-related events that impact on the trial. Where these events meet the definition of an intercurrent event in the ICH E9(R1) guideline, i.e. they "affect either the interpretation or the existence of measures associated with the clinical question of interest", they should be treated accordingly at the estimand level.
- Clinical Trials Regulation (Regulation (EU) No 536/2014)
- Points to consider on the impact of the war in Ukraine on methodological aspects of ongoing clinical trials
- Guidance on clinical trial management during the COVID-19 pandemic
- Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
- Advice to sponsors on managing the impact of the war in Ukraine on clinical trials
- Clinical trials in human medicines