The current war in Ukraine has had a huge impact on clinical trials in Ukraine, Russia and Belarus. Due to the war, a large number of patients in these countries participating in clinical trials are no longer able to participate. There are also problems with the supply of medicinal products and other supplies for conducting clinical trials. The relevant authorities in countries within the European Union are making every effort to ensure the continuity of treatment for patients in ongoing clinical trials by providing the option to continue their treatment at trial sites abroad.
Some of the patients who participated in clinical trials in Ukraine, Russia and Belarus have fled to countries within the European Union or are planning to do so. The relevant authorities in countries within the European Union are making every effort to ensure the continuity of treatment for patients in ongoing clinical trials by providing the option to continue their treatment at trial sites abroad.
Continue participation in clinical trial abroad
Sponsors with trial sites in Ukraine, Russia and Belarus must actively inform participants about the option to continue their participation abroad and provide them with a list of trial sites within the European Union where this clinical trial is conducted. If the trial site is no longer operational, clinical trial participants can contact the FAMHP or sponsor themselves. To ensure anonymity, the sponsor may not store personal data.
It is of course important for the patient to be able to continue the same treatment and that unblinding is prevented. The main goal is the structural continuation of the potentially effective treatment of the patient. Data collection is incidental as the transfer of the original data may have been obstructed.
Once the new trial site in the European Union has confirmed the transfer, the patient has to sign an informed consent form to agree to participate in the clinical trial at this site. The informed consent and any questionnaires must be written in a language that the patient understands. If the researcher does not speak the patient's language, the interpreter involved in conducting the interview will also sign the form.
The Clinical Trials Coordination Group of the Heads of Medicines Agencies (CTCG of the HMA) and the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission have published recommendations for sponsors with ongoing clinical trials in the European Union or European Economic Area.
If there is no trial site in Belgium that can provide continuity of treatment in the clinical trial, the FAMHP can be contacted to explore other options, such as providing the medicines used for compassionate use or medical need programmes.
Sponsors must report transfers
The FAMHP and the FPS Public Health Clinical Trial College or ethics committees ask to report patient transfers. The FAMHP requests confirmation of this report and of the written agreement of the trial site within the European Union to include the participant, taking into account the transfer of medical responsibility and the site's available capacity. Information about this trial site and the phase of the clinical trial (treatment/follow-up) must also be provided.
When reporting to the FPS Public Health Clinical Trials College or ethics committees, it must be ensured that all documentation for the participating patient (including informed consent) will be provided in a language the patient understands, as well as the medical and administrative care the patient will receive. If possible, this report shall be submitted prior to the transfer and no more than one week after the transfer of the participating patient.
When a new trial site is opened in Belgium or when the maximum number of participants in the clinical trial in Belgium increases by more than 10 %, a substantial modification (modification or amendment) has to be submitted to the FAMHP. The substantial amendment must be submitted within one month of transferring the participating patient, with the information as requested in the notification but also information about the number of patients, trial sites involved and insurance. In addition, additional measures may be taken by the sponsor to ensure the robustness and integrity of the data. The modifications must be described in the cover letter, with a link to the war in Ukraine. This modification may not be combined with other substantial or insubstantial modifications. The FAMHP and the FPS Public Health Clinical Trials College will handle this procedure as a priority.
Transferring clinical data
Sponsors must consider the possibility that it may not be possible to include the patient's original data in the statistical analysis. If this is possible, a risk analysis is required for the further use of this data in any potential marketing authorisation. Pending additional recommendations on the methodological aspects of data impacted by the war in Ukraine and the use of this data for market authorisations, European or national scientific advice may be requested.