Clinical trials and the war in Ukraine
The war in Ukraine is also affecting clinical trials in Ukraine and jeopardizing the safe treatment of trial participants. The member states of the European Union have adopted a common strategy to enable the continuation of treatment of study participants and the continuation of clinical trials as quickly and easily as possible.
Recommendations of the Clinical Trials Coordination Group (CTCG) for clinical trials with medicinal products in the EU/EEA
In the following you will find the specific regulations for Austria in addition to the European recommendations.
Is it possible to transfer participants in a multinational clinical trial from a trial site in Ukraine to a trial site in Austria to continue treatment?
Yes, when the same clinical trial is also authorised in Austria. It is at the discretion of the sponsor of the clinical trial whether to use this option and allow the transfer. The responsible investigator at the Austrian site should also be involved.
Who should serve as a contact point for the participant to transfer within the trial?
The primary contact point for the Ukranian participant should be the Ukranian trial site, if possible. The trial site should then inform the sponsor, and the sponsor should coordinate the transfer with the Austrian trial site.
If contact to the trial site is not possible, participants could contact the sponsor directly. However, in such a situation it needs to be guaranteed that the identity of the participant is protected e.g. via coordination by an independent sub-unit of the sponsor or a third party. Data on the identity of the participant should not be stored.
In exceptional cases the the BASG could serve as an initial contact point for participants. For this purpose sponsors need to provide the BASG with contact points for Austrian trial sites that can accept Ukranian patients. BASG will then provide this contact information to patients based on the trial identification numbers.
How should patient transfer be notified to the responsible Ethics Committees?
An informal notification before the transfer is sufficient, which should confirm/include the following:
- All patient documents should be available in a language understood by the patient. The usual requirement is that the patient documents (including the participant information) should be available in a certified translation.
- Trial participants need to agree to the modalities of transfer in writing. Since participants have already agreed to participate in the trial itself in their home country, the consent may be limited to the transition and special National regulations (e.g. data protection).
- In case of urgency the Ethics Committe can agree to a handwritten consent in addition to the Ukranian informed consent. In such cases informed consent based on a translation of the Austrian Informed Consent Form is necessary as soon as possible.
- It needs to be guaranteed that medical and administrative care for the patient is provided in a language that is understood during the entire time the patient is in the trial in Austria
- The sponsor should bear in mind that not all Ukranian patients are fluent in Russian or might refuse to use Russian due to the emotional trauma of war and expulsion. Where possible, the sponsor should make use of Ukranian translations and translators.
- It should be ascertained whether the insurance for clinical trials in Austria will cover such patients; otherwise the insurance agreement would need to be amended accordingly.
How should this transfer be notified to the BASG?
An informal notification within one week after the transfer is sufficient. The notification should include:
- the confirmation of the notification to the Ethics Committee
- the information to which trial site in Austria the patient has transferred and
- whether he/she is receiving treatment or is only in follow-up.
How will transferred patients receive their study medication and treatment?
General medical treatment and trial-specific treatment will be the responsibility of the Austrian trial site. Sponsors need to make sure that an adequate supply of IMP is available at the site to secure the ongoing treatment of the patient. Sponsors also need to ensure that trial sites are reimbursed for any additional medical care required in the context of the clinical trial (examinations, hospitalisation...).
In these cases, is labeling of the investigational medication in Ukrainian required?
For study medication administered by the investigator or other study personnel, labeling in Ukrainian is not required.
For study medication managed by the participant, the investigator should ensure understanding of the minimum information required by the Labeling Regulation § 50. It can be assumed that a new labeling in Ukrainian will not be necessary in the vast majority of cases, as long as the requirements of § 50 para. 1 can be ensured through the use of accompanying documents.
If a substantial amendment is required for changes specifically related to the war in Ukraine, is there the possibility to perform an expedited process for the review and approval?
Yes. The changes should be described in the cover letter and justified as specifically related to the war in Ukraine. Such amendments should not be grouped together with other substantial or non-substantial changes for which regular review timelines are feasible.
What are the options to continue treatment in case the same trial is not authorised in Austria?
Recruitment into another trial (e.g. a catch-up protocol) or an authorised Compassionate Use Program could be an option. Otherwise, the remaining option is the treatment under Named Patient Use. This, however, would require a treating physician in Austria. Companies offering Named Patient Use for patients from Ukraine, Russia or Belarus should also provide contact information to the BASG.