The pilot of the clinical trial evaluation process is progressing as planned
The pilot of the clinical trial evaluation process is progressing. The first evaluation under the new process has been successfully completed. This is based on the EU Regulation on Clinical Trials, which changes the regulatory assessments of medicines.
The experiences with the first evaluation are good.
"We stayed on schedule and received good feedback. According to the feedback, the instructions were clear and the process worked,” says Outi Konttinen, Secretary-General of National Committee on Medical Research Ethics TUKIJA, which operates in connection with Valvira.
Digitalisation supports the smoothness of the new evaluation process, according to Konttinen:
"We have switched to electronic processing of applications, which supports the preparation for changes in accordance with the EU Regulation on Clinical Trials."
New clinical trials welcome top participate in pilot
According to the current assessment, the application of the EU Regulation on Clinical Trials will start in January 2022. Commissioners of pharmaceutical research can prepare for the implementation of the future regulation by participating in a pilot.
"There has been a commendable interest in participating," says Outi Konttinen.
"Two studies are currently being piloted and, additionally, we have already made a preliminary decision on the other two studies to be piloted. We welcome new applications as well."
The number of clinical trials conducted in Finland yearly is between 130 and 180. The most significant commissioner of pharmaceutical studies is the pharmaceutical industry, but there is also a lot of academic pharmaceutical research in Finland.
The National Committee on Medical Research Ethics TUKIJA is piloting the new evaluation process together with Fimea, the Finnish Medicines Agency.
More information is available from:
Outi Konttinen, Secretary-General, National Committee on Medical Research Ethics TUKIJA, tel. +358 (0)295 209 547
Further information on the EU Regulation on Clinical Trials and on the guidelines of participating in the pilot (fimea.fi)
More information about TUKIJA (tukija.fi)