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Starting clinical trial in Finland

Before a new trial is started, it 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). In the CTIS, notifications are checked simultaneously by different European medicines authorities and ethics committees. 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. In the CTIS information system, processing times are specified in the EU Medicines Research Regulation for the activities of the authorities. For drug trials, the entire process typically takes a maximum of about 60 days if there are no requests for additional information. Processing times for medical device investigations vary from approximately 10 days to 65 days, depending on the regulation (MD or IVD) and the risk class (I-III) of the device being studied.

In addition to these, in Finland, 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. The research requires an experienced researcher in charge of the research, suitable facilities and equipment, and trained personnel. The trial must be feasible in practice and applicable to current treatment practices. A clinical trial agreement is always made between the Sponsor and each research unit. The agreement always includes a research budget.

The total times required for the evaluation of the regulatory authorities, the trial agreement negotiations and the hospital’s research permit vary between research centers. Research permissions and research agreements of research units are processed and approved in accordance with each research unit’s own administrative guidelines and deadlines. The average time required for a research permit and signing contracts in Finnish university hospitals is about 30-60 days.