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Ukraine conflict: Impact on clinical trials

Both the Clinical Trials Coordination Group (CTCG) and the Portuguese National Authority of Medicines and Health Products (INFARMED) have recently issued guidance on the management of the impact of the Ukraine conflict on clinical trials and respective participants.

To address the impact of the conflict in a homogeneous and structured way, the CTCG published recommendations providing the main requirements in terms of protection, safety, and rights of the participants in clinical trials affected by the conflict.

The recommendations focus on the transfer of trial participants from centres in Ukraine to centres in the EU/EEA within the same multinational clinical trial. They follow the European Medicines Agency’s advice to sponsors, dated 30 March 2022, to use the experience gained during the COVID-19 pandemic and apply the requirements and waivers agreed in this context.

INFARMED issued a bulletin on the integration of Ukrainian refugees entering the country in clinical trials. The information in this bulletin applies to participants in clinical trials that are being held, simultaneously or not, in Ukraine and EU Member States.

INFARMED directs health entities responsible for profiling medical histories of refugees entering Portugal to identify the clinical trial and its respective sponsor. Once identified, health entities are instructed to contact the sponsor to assess if the clinical trial is currently being conducted in Portugal, and which research centres can integrate the participant.

If the clinical trial is not being conducted in Portugal, and the investigational medicinal product in question does not hold a marketing authorisation, verification of alternative therapeutical options is determined. As a last resort measure in the absence of alternative therapeutical options, a request for Exceptional Use Authorisation of the medicinal product can be considered.

Tags

clinical trials, europe, pharmaceuticals

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