Paediatric Clinical Trials
Before starting a clinical trial in Finland, including also pediatric trials involving children aged 0 to 17 years, the study protocol and research plan must pass several regulatory evaluations before the trial can be started. Medical research and clinical trials on human subjects are strictly regulated by law and supervised by drug regulatory authorities.
The Finnish Medicines Agency, Fimea needs to be notified about the trial plan as it authorizes study start. The study plan must also be submitted to The National Committee on Medical Research Ethics (TUKIJA) for an ethical evaluation and opinion. 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, 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.
In Finland, authorities' processes and processing timelines are regulated by law and related standard operating procedures. Research permissions and trial agreement processing periods in hospitals/ clinics vary depending on respective administrative procedures and requirements.