Due to unavailable or missing source data, the clinical trial sponsor has to take into account the possibility that data obtained from Ukrainian patients will not be included in the final statistical processing of the clinical trial results, nor can they be used for the product registration. The primary objective of ensuring further participation of clinical trial subjects is to have continuous access to the investigational treatment that they are likely to benefit from, and also to continue monitoring patients for safety.
If the patient does not wish to continue to participate in the clinical trial, but has benefited from the treatment according to their Estonian 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.
Transferring clinical trial subjects form Ukraine to Estonia, the following must be taken into account:
- Clinical trial must be authorized and ongoing in Estonia.
- There should be a site/investigator available that is capable to recruit more patients.
- Insurance. It should be ascertained whether the insurance for clinical trials in Estonia will cover foreigners or whether the inclusion of foreigners is in the insurance exclusion. Insurance must cover the higher number of patients.
- Language barrier and informed consent. Patient information should be repeated and informed consent should be retaken. If the patient is not fluent in Estonian nor Russian, the patient information sheet and informed consent form valid in Estonia should be translated into Ukrainian by an officially certified provider. In the latter case, since the 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 sponsor is also responsible for the timely translations of the patient diaries and manuals, if applicable.
If the clinical trial subject speaks Estonian or Russian, even though it is not their mother tongue, the participation of an interpreter is not necessary during study visits (except patient information procedure), though this needs to be properly documented in the patient files.
- IMP. IMPs for transferred clinical trial subjects need to be secured and delivered to sites in Estonia so that the patients will continue in the original assigned treatment arm and will receive the same treatment that they used to.
- The Estonian sites need to be reimbursed for any additional medical care required in the context of the clinical trial.
- The sponsor should assist with arranging transport to the trial site as clinical trials subjects may not be accommodated at the same place where the clinical trial is taking place.
- The sponsor should make every effort to transport of health care data related to the patient to the site in Estonia, 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 complying with the Estonian Personal Data Protection Act (publication reference: RT I 04.01.2019, 11)1.
- The sponsor needs to keep in mind and follow the data protection regulation throughout the clinical trial.
With regard to patient transfer, the following documents should be submitted as non-substantial amendments to the national competent 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 (e.g time already spent in the clinical trial, treatment status, nature of necessary treatment in the future, risks of not receiving treatment, measures for protecting patient safety when continuing collecting of safety data etc.). In addition, the trial site should be described (institution, investigator, declaration that the site is suitable and willing to receive more patients).
- Sponsor’s declaration that patient information material for participants whose mother tongue is not Estonian nor Russian was translated into Ukrainian by a officially certified provider, based on valid Estonian documents. Documents in Ukrainian should not be submitted.
- Insurance covering the higher number of patients.
The Clinical Trials Coordination Group (CTCG) has also published a recommendation paper to sponsors, which is accessible here.
Viimati uuendatud: 06.04.2022