Transfer of a trial subject from centres in Ukraine to centres in the Czech Republic
It is possible to transfer a trial subject (hereinafter referred to as "TS") participating in a clinical trial at a centre in Ukraine to a centre in the Czech Republic in order to continue treatment. However, it is at the discretion of the sponsor of the clinical trial whether to use this option and allow the transfer of Ukrainian TS. In this case, the following should be noted and taken into account:
- Given the situation, source data are unlikely to be available, with uncertain access to source data after the end of the war in Ukraine. The sponsor has to take into account the possibility that these data obtained from Ukrainian TS will not be included in the final statistical processing of the clinical trial results, nor can they be used for the product registration or a change to the registration.
- Insurance – it should be ascertained whether the insurance for clinical trials in the Czech Republic will cover foreigners or whether the inclusion of foreigners is in the insurance exclusion. If so, the insurance agreement would need to be amended accordingly. Although refugees will be insured by VZP (Note: Všeobecná zdravotní pojišťovna – public insurance provider), but this will probably only cover routine medical care, it cannot be assumed that this insurance would include research purposes.
- IMP – IMPs for transferred TS need to be secured and delivered to centres in the Czech Republic so that TS continue the same treatment started. (Note: sending IMP from the centre in Ukraine is not feasible at the moment).
Note: In the questions about this situation, the possibility of sending medicinal products (IMPs) directly from the centre in Ukraine to the TS was also mentioned. In this case, it is not a transfer of TS from the centre to the centre, TS would continue to be registered in the centre in Ukraine, so we will not comment on this possibility.
If the TS were to be transferred to a centre in the Czech Republic and their IMP could be distributed, provided transport conditions to the Czech Republic are ensured, they should be delivered to the centre where the TS will be transferred.
- Ensure that the centres are reimbursed for any additional medical care required in the context of the clinical trial (examinations, hospitalisation...).
- Case Report Forms (CRF) are nowadays in electronic form, there should be no problem for Czech centres to continue filling them in. The information from CRF should also make it clear at what phase of the clinical trial the TS is.
- Electronic versions of patient information/informed consent in Ukrainian or Russian will also be available. TS should sign the current version of the document after the transfer to the Czech centre, indicating that he/she agrees to continue participation in the clinical trial in the Czech Republic.
- The sponsor should assist with arranging transport to the centre as TS may not be accommodated at the same place where the clinical trial is taking place. E.g. by covering travel costs.
- It is also necessary to address the possible capacity of the centre, possibly increasing the planned number of TS. The sponsors or the designated persons need to contact the centres in the Czech Republic in advance to find out the current situation and the possibility of transferring Ukrainian TS.
- Language barrier – it is also necessary to address the issue of language barrier. There are Ukrainians working in many health facilities who could help with interpreting. Again, the current situation needs to be ascertained by the sponsor.
The intention to transfer TS from one clinical trial centre to another does not have to be approved by SÚKL, the sponsor will either notify the institute by letter or mention it in the annual report on the clinical trial.
The HMA recommendation for the transfer of TS from UA centers to EU centers was published on 5 April 2022.
https://www.hma.eu/about-hma/recently-published.html
https://www.hma.eu/about-hma/working-groups/clinical-trials-coordination-group.html
8 March 2022
Department of Clinical Trials on Medicinal Products
cz