OGYÉI position on the continuation of clinical trial participation in Hungary for refugee patients who are enrolled in clinical trials in Ukraine

Continuation of trial participation in Hungary for patients who were enrolled in Ukraine, if the same study is also being conducted in Hungary:

These patients can continue their participation in the clinical trial, if the conditions outlined below are met.

The leading aspect is, according to the GCP principal and in line with the legislation, ensuring the safety, rights, and dignity of trial subjects. It should be stressed that the main responsibility for patient safety and wellbeing remains at the sponsor. During the establishment of this position, the primary objective was to ensure that patients enrolled in clinical trials in Ukraine can continue to receive the treatment they need.

If the patient does not wish to continue to participate in the trial, but has benefited from the treatment according to their Hungarian physician too, the sponsor should consider the possibility that the patient receives the investigational medicinal product within the legal framework of compassionate use, if the patient gives consent. Legal basis for this is outlined in Government Decree No. 448/2017 (27 Dec).

1. According to Government Decree 86/2022 (7 Mar) on Rules of Temporary Protection and on the different application of rules of Act CVI of 2011 on Public Employment and on the amendment of Acts related to Public Employment and other Acts, the subject coming from Ukraine should have asylum or other status entitling them to receive appropriate health care (normally asylum seekers or refugees, but it is the responsibility of the sponsor to verify eligibility).

2. The particular clinical trial is authorized and ongoing in Hungary.

3. Patient information and proper communication between sites and patients should be provided throughout the whole clinical trial (e.g. with the help of an interpreter, but a relative, friend or acquaintance whom the patient trusts is also acceptable).

The sponsor should ensure the timely translation of the patient diary (if applicable), as the investigator needs this to make decisions related to the patient’s treatment.

If the patient speaks Hungarian, even though it is not their mother tongue, unlike the patient information procedure, the participation of an interpreter is not necessary during medical consultations.

4. There is no country-specific requirement that would prevent patients previously treated in Ukraine to be eligible for enrollment in Hungary.

5. There should be a site/investigator that can receive more patients.

6. Patient information should be repeated, and informed consent should be given once more. If this is done, then patients can continue their clinical trial participation at a Hungarian site. It is not possible that a Ukrainian physician informs the patient about/after their admission.

The patient information may be in Hungarian, if the patient speaks Hungarian. If not, patient information should be provided in their mother tongue. Since verbal information and consultation is a mandatory part of the patient information procedure, this needs to be done with the help of an interpreter provided by the sponsor, or a third person accepted by the patient (e.g. a relative). The patient information sheet and informed consent form valid in Hungary should be translated into Ukrainian by an official certified provider.

7. The sponsor needs to ensure, in accordance with the data protection rules, the transport of health care data related to the patient, at least those that are essential for the patient's safety and safe treatment (e.g. medical history, medical status at the time of enrollment and its changes, previous (S)AE-s, etc.). Some of these are likely to be available in the eCRF. Transfer of necessary data to the investigator is the task and responsibility of the sponsor, while keeping in mind the data protection rules.

Regarding further information on the accordance with the data protection regulation, we advise the sponsor to contact a specialist in data protection law.

8. The sponsor needs to clarify how to be in line with the data protection regulation if the patient returns to Ukraine and health care data generated in Hungary needs to be transported back to Ukraine.

9. In order to ensure the robustness and integrity of data, further measures may be introduced by the sponsor. The sponsor should carry out a risk assessment in terms of further use of data of patients who started their trial participation in Ukraine and continued it in Hungary. The sponsor needs to bear in mind that patient data by default cannot be used in the clinical trial, since transfer of source data is presumably not feasible in the current situation, and cannot be controlled later either. It should be stressed at this point too, that the primary objective of ensuring further participation of clinical trial subjects is that they have continuous access to the investigational treatment that they are likely to benefit from.

Documents

With regard to patient transfer, the following documents should be submitted as non-substantial amendments to the authority and to the ethics committee.

• cover letter, which describes the reason and circumstances of the intended patient transfer, with a brief justification that continued participation in the clinical trial is in favour of the patient (time spent in the clinical trial already, treatment status, nature of necessary treatment in the future, risks of not receiving treatment, etc.). In addition, data of the trial site should be described (institution, investigator, declaration that the site is suitable for receiving more patients).
• sponsor’s declaration that patient information material for participants whose mother tongue is not Hungarian was translated into Ukrainian by a certified office for translation, based on valid Hungarian documents. Documents in Ukrainian should not be submitted. (The declaration may be a part of the cover letter.)
• insurance covering the higher number of patients – refugee patients are to be added to the number of participants at the site, therefore, renewal of insurance is necessary