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Pediatric clinical trials

Pediatric Clinical Trials

Before starting a clinical trial in Finland, including also pediatric trials involving children (aged <18 years), the study protocol and research plan must pass several regulatory evaluations before the trial can be started. Medical research and clinical trials on humans are strictly regulated by law and supervised by regulatory authorities.

The Finnish Medicines Agency, Fimea needs to be notified about the new clinical trial as it authorizes study start. The study plan must also be submitted to central Ethics Committee The National Committee on Medical Research Ethics (TUKIJA) applying for a ruling from TUKIJA on whether the ethical admissibility of the proposal is to be reviewed by TUKIJA or by one of the regional ethics committees. Clinical trials need to be evaluated by both authorities before study start. After regulatory evaluations, the Sponsor must apply for research permission from all those organizations (clinics / hospital departments) where the trial will be conducted.

Trial agreements are signed between the Sponsor funding the trial and the organization 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 and Hospital Reserach Permission timelines

In Finland, the regulatory authority assessments and hospital research permissions can be processed in a parallel manner, and the applications and notification can be submitted to authorities simultaneously. The authorities’ processes and processing timelines are regulated by law and related standard operating procedures. Ethics Committee provides opinion within 60 days since having received an appropriate application, similarly the Finnish Medicines Agency will assess the new clinical trial notification within 60 days, after receiving notification. For gene therapy- and cell therapy products or products including genetically modified organisms the assessment time is extended to 90 days, and may be further extended to another 90 days, if the assessment requires extensive further investigations.

Research permissions and 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 (after Ethics Committee positive opinion) and signing the Clinical Trial Agreement is 30 to 60 days.