Reform of clinical trials requires operators to update their competence
Clinical trials are a prerequisite for effective healthcare and its development. They help create jobs and provide hospitals with investigational medicinal products free of charge. Trials also have huge significance for the national economy, as investment in research and development in 2021, for example, totalled EUR 234 million.
Patients also gain an important opportunity to participate in trials. Participating in trials may be the only treatment available for some patients, and participation in trials has even been found to save lives.
“Finland’s strength in trials is its effective, tax-funded national healthcare system and highly qualified staff. In addition, the general public has a very positive attitude towards clinical trials, they are keen to participate and carefully follow the instructions. This helps produce highly reliable results,” says Mia Bengtström, Senior Adviser for Pharma Industry Finland.
Clinical trials always require authorisation. The authorisation practices have been a little ambiguous and the interpretations of the regulations have varied; however, the operations of the authorities in Finland are, as a rule, very consistent. The authorisation process has now been reformed with the aim of harmonising the processes within the EU as well as streamlining and facilitating the work of researchers and enhancing the clinical trial assessment process.
New EU regulation will change the way things are done
The EU Clinical Trials Regulation entered into application on 31 January 2022. The aim of the Regulation is to facilitate the conduct of clinical trials by speeding up the assessment of trials by the authorities, by standardising European practices and streamlining the application procedures. The aim is also to improve the competitiveness of the EU as an attractive location for clinical trials.
Clinical trials were previously assessed separately in each Member State. The new EU Regulation will replace national assessment processes with a European-wide prior authorisation procedure. In the future, the assessment of clinical trials will be carried out through the Clinical Trials Information System (CTIS) EU portal maintained by the European Medicines Agency (EMA).
“The sponsors of a clinical trial must submit authorisation applications electronically via the EU portal to all of the Member States where the trial is to be conducted. The applications will be evaluated by the national medicines agencies of the Member States, led by a single Member State, which will speed up the application process. In addition to harmonising the practices of the Member States, the EU Regulation also establishes stricter time limits for the processing of applications, which will make the timelines more predictable,” Bengtström says.
The new regulation concerns commercial entities and academic researchers alike. The first three years of the application of the Regulation form a transition period, during which sponsors may submit their applications either under the new EU Regulation or the previous EU Directive.
Competence development will be key
For high-quality trials to continue, up-to-date competence will be required. Those carrying out trials will have to be familiar with the changing legislation, research and authorisation processes and reporting of adverse reactions. When conducting trials, it will also be necessary to know how to compile a protocol for the trial. The new EU regulation will harmonise the practices, but operators will have to update their knowledge and familiarise themselves with the new processes.
“Pharmaceutical research is like a moving train: new interpretations come along all the time and you won’t get far with outdated skills. Continuous training is absolutely vital in this area. Those carrying out clinical trials will be required to continuously supplement their knowledge, participate in further training and update their CVs,” says Bengtström.
The Pharmaceutical Information Centre supports professionals carrying out clinical trials by providing a comprehensive selection of training for different needs. The popular GCP Web Test, which is available in English, has been updated in accordance with the new EU Regulation. The test is also available in Finnish and Swedish (for the Swedish market). The Pharmaceutical Information Centre’s GCP tests are approved by TransCelerate.