All clinical trials now begin in compliance with the EU Regulation

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During the transition period of clinical trials, a second phase was introduced on 31 January 2023. Since that date, all beginning trials have been processed via the CTIS portal ( Trials that started before that may continue in compliance with the Clinical Trials Directive as long as they have been transited, i.e. successfully transferred to comply with the EU Regulation at the end of January 2025.

In 2023, before the end of January, there were 17 new trial notifications under the Directive. In the whole year, 494 change notifications were submitted to trials in compliance with the Directive. 
In 2023, Finland received a total of 145 trial applications in compliance with the EU Regulation, 91 of which were entirely new trials. Thus, the total number of new trial applications was 108, when including the trials in compliance with the Directive. The number remained practically the same compared to 2022 (107).

46 applications were transits, i.e. transfers from a study under the Directive to comply with the Regulation. As for new studies, Finland acted as the reporting member state (RMS task) for 24 multinational studies. There were 24 national trial applications. Finland was added 7 times to a study that started elsewhere. 

Changes brought about by the Regulation

Compared to the previous national evaluation, the EU Regulation contains a joint assessment between the other participating countries in multinational studies. In Finland, Fimea and Tukija participate in the assessment, instead of the previous assessments carried out separately in each country.

The EU regulation also recognises a low intervention rate trial, which has not previously been recognised by legislation. In such a trial, the investigational medicinal product must have a marketing authorisation, the investigational medicinal product is used in compliance with the marketing authorisation, or its use is based on published scientific evidence, and the additional risk or burden on the safety of the subjects caused by additional diagnostic and monitoring methods is minimal compared to normal practice. 

In addition, an emergency trial is recognised, in which, on certain grounds, an informed consent can only be requested from the participant after placing in the study. The EU Clinical Trial Regulation (536/2014) also defines clear criteria for the requirements of the clinical trial’s trial protocol and its approval by the authority. 

Fimea communicated actively 

During the year, Fimea organised three webinars on research themes, focusing on various changes and scientific issues in research plans. The themes included device studies combined with drug trials, the use of real-world data in drug trials, paediatric drug trials and CTIS experiences and advice. At best, approximately 200 listeners attended the webinars at a time. 

A total of 14 online news items were published during the year. The topics included transferring new applications to the CTIS portal only, transitions, changing transparency rules, various EMA workshops and changing national legislation on register data. The news articles are available on Fimea's website. Researchers were also reminded of the need for transition by email. 

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