Upward trend in the number of new clinical trials
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There was a slight rise in the number of new clinical trials in 2024. There were 113 in all. In 2023 the figure was 108. Finland was the Reference Member State in 41 studies, of which 20 were multinational. Finland was a Concerned Member State in 49 studies and was added to a study that had begun elsewhere on 23 occasions. Of the new research applications, seven were withdrawn, one expired, one did not get through the preliminary validation stage, and one was rejected.
The most challenging work for the authorities and the investigators related to the home stretch of the transition phase. Since the end of January 2023, all new trials have been processed via the CTIS portal (euclinicaltrials.eu), but trials that had started prior to that date have been able to 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 by the end of January 2025.
In autumn 2024, Fimea contacted all researchers and/or trial sponsors that had not submitted a notice of termination or effected a transfer to comply with the new EU Regulation. In all, 440 trial researchers or sponsors were contacted so that the official measures in relation to trials would be carried out. A Finnish-language video was also put together for academic researchers to provide technical support for the transition. In 2024, 177 such transitions were carried out.
During that year, 127 significant changes were made to studies under the Directive and there were 326 significant changes to studies under the Regulation.
Call for research trial participants
At the end of January 2024 there was call on the Fimea website for physicians and potential trial participants, giving details of current studies in need of subjects. There is a request for the notification of all newly approved trials to be posted there by the time recruitment starts. As the notification to say that recruitment has ended must be posted on the CTIS portal, the studies are removed from the site when the notification arrives.
Fimea communicated actively
During the year, Fimea organised three webinars on matters to do with trials. The topics covered included the repeated sessions ‘CTIS-practical help for researchers’ and ‘Topical issues related to the ethical evaluation of studies’ plus, for example, the value of clinical trials for Finland, biobanks, GCP inspections, national scientific advice, and the STARS project to support academic researchers. As many as 200 or more people at a time attended the webinars.
Altogether, 40 online news items on topical matters related to clinical trials were published during the year. The subjects included the call on the website for trial participants, transitions, changing transparency rules, various EMA or ACT EU workshops, and the progress of the harmonisation of assessment processes for combined studies of medicines and medical devices (Combine). The news can be found on the Fimea website.