Clinical studies 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 approach to enable the continuation of treatment of study participants and the continuation of clinical trials as quickly and easily as possible.
For whom is this information intended?
This information is relevant to you if you
- are a patient currently participating in a clinical trial of a medicinal product in Ukraine, and
- have come or are planning to come to the European Union (EU) and
- need to continue treatment under the clinical trial, for example, if you have a serious or life-threatening condition
1) You are still in contact with the trail site Ukraine.
Please contact your investigator at the trial site in Ukraine. The contact information can be found in the informed consent form you signed or in the patient card you may have received.
The investigator should then contact the sponsor of the study, who is responsible for the entire study.
The sponsor will tell your doctor where in the EU the study is also running and at which EU trial sites you could continue your treatment. The sponsor will also coordinate the transfer and provide you with further guidance and contact information.
2) You have no contact with the trial site in Ukraine.
Please contact the study sponsor who is responsible for the entire study. Contact information can be found in the consent form you signed, in the patient card you may have received, or on a package of study medication.
Using the "EudraCT number" (a study identifier in the format "2XXX-XXXXX-XX") from one of these sources, you can also find the sponsor's contact information in the EU Clinical Trials Register.
The sponsor may need to refer you to an independent contact person, as they are not allowed to know your name or personal data for legal reasons (so called "anonymization"). Therefore, please limit the personal data you provide. This is also the reason why option 1) is preferable.
The sponsor or his independent contact will then inform you where in the EU the study is also running and at which EU trial sites you could continue your treatment. The sponsor will also take care of the transfer and give you further advice and contact information.
3) Options 1 and 2 are not available for you and you are currently located in Austria.
Please contact the Clinical Trials Department at the Austrian Medicines and Medical Devices Agency at firstname.lastname@example.org.
If you provide us with the "EudraCT number" (a study identifier in the format "2XXX-XXXXX-XX") of your trial, we can try to connect you with the trial sponsor's representative in Austria or a responsible physician at an Austrian trial site.
You can find the EudraCT number on the informed consent form you signed, on a patient card you may have received, or on a package of study medication.