The fourth annual NTA stakeholders meeting, “Potential in Nordic Clinical Research Cooperation”, was held in Oslo 26 January 2016 and opened by the Norwegian Minister of Health and Care services, Mr Bent Høie. He stated that we have only seen the start of a Nordic collaboration on clinical research and we need to build on the work that has been achieved by Nordic Trial Alliance.
Around 70 people attended the stakeholder meeting that took place at the grand Hotel Bristol in the centre of Oslo. Mr Høie greeted the audience and underlined the importance of the work that NTA has carried out over the last three years. “I know that Nordic collaboration is looked upon with great interest by the outside world. Together, the Nordics are becoming a leading region of knowledge. I believe there is an unreleased potential for a strong Nordic collaboration in the health sector and one of the areas of greatest potential is, in my view, Nordic collaboration in clinical research”, the minister stated.
Mr Høie continued by arguing why there is a strong need and potential for Nordic cross-border cooperation in clinical trials.
“Nordic collaboration on clinical research and health registers is increasingly relevant, especially in the light of the development of personalised medicine. The Nordic countries share similarities, both within research groups and research infrastructure. The Nordic population trusts clinical research, which is evident from the number of patients willing to participate in clinical research, and the Nordic countries are attractive to the pharmaceutical industry with a total population of 26 million”, he explained.
He also raised the question on how we ensure that NTA’s effort will continue after 2016, given the need to increase the number of clinical trials in the Nordic region. Høie answered the question himself.
“We need to take into account the new developments in technology and personalised medicine, with smaller patient groups. In this context, Nordic and international collaboration is essential. I believe we should pursue Bo Könberg’s proposal on ethical review of clinical trials. This should be part of the future Nordic collaboration on clinical trials and health registers. The Norwegian Ministry of Health and Care Services is looking at how we can collaborate on clinical trials and ethical reviews, after 2016, Høie said before adding an encouraging quote:
“Norway acquires the chairmanship of the Nordic Council of Ministers in 2017. This represents an opportunity to take our initiatives forward. The future health challenges in the Nordic region cannot be handled by one country alone and by joining forces, we will be able to achieve more, in favour of the patient and the future health services,” he concluded.
After Høie’s speech, Pierre Lafolie, NTA’s project leader took the stage and presented the background of NTA, its original targets, the features of the NTA website, and the main achievements from the last three years.
“By conducting pan-Nordic studies it will be easier to determine the effects of new pharmaceuticals and treatments on patients and patients will have access to new effective treatments earlier. I hope that NTA have contributed to creating better awareness about this and strengthened the Nordic cooperation in clinical research and research infrastructures, Lafolie stated.
Before lunch, Mika Scheinin (Nordic Research Ethical Procedures), Annette Jørgensen (Nordic Monitoring Network), Pirkko Leopola (Nordic Pediatrics Network) and Christian Gluud (Nordic clinical research transparency and registration), all gave interesting insight into the NTA implementation projects. Download their presentations below.
The latter part of the day was divided into two parts. Professor Steinar Aamdal from Oslo University Hospital moderated the first part, which covered national country reports from the Nordic countries and talks from the Regional Managing Director Northern Europe of TFS, Jan Hellqvist and Legal Adviser, Marjut Salokannel.
Mr Hellqvist gave a talk from the industry’s point of view, titled “A CRO perspective on what would attract more Clinical Trials to the Nordic Region”. He advised the Nordic countries to act as one strong area and with one ethical application for the whole region. Hellqvist also mentioned that as the Nordic region is highly competitive in terms of cost and quality of clinical studies, it should take note from lessons learned in Poland and Denmark on infrastructure and change management, in addition to focus on early and late phase clinical research.
Ms Salokannel presented her talk on “Common Nordic Legal Framework for Future Research”. She stressed that a way forward for Nordic cooperation in the area included secondary use of clinical trial data for research and product development, and common ethical parameters for the scope of consent relating to processing health related data for scientific research. She also added that common legislation to organisational and technological safeguards for processing sensitive personal data for scientific research purposes was of great significance.
The stakeholder meeting ended with a panel discussion moderated by NTA’s Project Leader, Pierre Lafolie. The panel consisted of Jacob Hølen, Director of The National Committee for Medical and Health Research Ethics (NEM), Bjørn Eiriksten, CEO of Oslo University Hospital, Mia Bengtström, Senior Adviser at the Pharmaceutical Association in Finland, Jørgen Frøkiær, Chairman of the Danish Council for Independent Research | Medical Sciences and Ole Alexander Opdalshei, Deputy Secretary General of The Norwegian Cancer Society.
One major discovery during the NTA project was that it is possible to start the process for a common Nordic research area by individual countries accepting the research ethical reviews of other Nordic countries. With such a stepping stone further development is possible.
“New thinking is necessary and establishing a joint ethical committee may be one way to open for cooperation in different research fields”, stated Jacob Hølen on the matter.