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Pediatric clinical trials

Pediatric Clinical Trials

In Finland, all clinical drug trials (also pediatric trials involving children aged <18 years) must pass several regulatory evaluations before the trial can be started. Clinical trials on humans are strictly regulated by laws and supervised by regulatory authorities.

From 31 January 2023, all new Clinical Trial Applications (CTA) for academic and commercial clinical drug trials in the EU and EEA must be submitted through the Clinical Trials Information System (CTIS) of the European Medicines Agency (EMA). This change is based on the Clinical Trials Regulation (EU) No 536/2014 (CTR), which came into application on 31 January 2022. The Regulation is designed harmonise the processes for application, assessment and supervision of clinical trials in the EU. The CTR includes a three-year (2022-2025) transition period for those clinical trials submitted earlier under the preceding Clinical Trials Directive 2001/20/EC (CTD) and which are still ongoing. These trials need to comply with the CTR and must be transferred also to the CTIS by 30 January 2025.

The CTIS supports the flow of information between clinical trial sponsors and EU Member States regulatory authorities and Ethics Committees and provides a common platform for the CTA assessment simultaneously. Clinical trials conducted in Finland are assesed by the Finnish Medicines Agency, Fimea and The National Committee on Medical Research Ethics (TUKIJA) within the CTIS. After CTIS submission, the Sponsor must apply for Research Permission from all those organizations (clinics / hospital departments / private clinical centres) where the trial will be conducted in Finland. All clinical drug trials in Finland must be condusted according to the Act on Clinical Trials on Medicinal Products (983/2021).

Trial agreements are signed between the Sponsor funding the trial and the organization (trial site) in question. In addition, the trial must have an experienced and licensed Principal Investigator, appropriate research facilities and equipment, and trained study personnel. The study protocol needs to be feasible enough to be conducted in practice and it must conform with the standard of care.

Before the trial can be started in practice, participants (children and/or guardians/ legal representatives, depending on the age of the child) need to sign voluntary Informed Consent documents to confirm study participation. Informed Consent is based on the provided Patient Information that needs to be understood and approved before signing the Informed Consent. The child’s own opinion and supposed will must be obeyed taking into account his/her age and level of understanding.

Regulatory Authorities assessment, Clinical Trial Agreement and Reserach Permission timelines

The CTR sets the legal timelines for both the regulatory authority and the ethical assessments in the CTIS. This timeline for these both assessements in a parallel manner is 60 days. This dead line may be further extended to another 46 days in case that Requests for Information (RFIs) are raised during the assessment period. The overall timeline for the substantial CTA Modifications is 50 days and this timeline may be further extended to another 46 days in case that Requests for Information (RFIs) are raised during the assessment period.

Research permissions and clinical trial agreement processing periods in hospitals/ clinics vary depending on respective administrative procedures and requirements. In Finnish University Hospitals the average time for granting the research permission and signing the Clinical Trial Agreement is 30 to 60 days.