The Nordic Trial Alliance (NTA) annual stakeholder meeting 2015 took place at the Paasitorni Hotel and Conference Center in Helsinki, and this year’s topic was Nordic cooperation on ethical review procedures. During the meeting, differences in legal frameworks and common Nordic practices in ethical review procedures in clinical research were discussed.
The aim of the meeting was to identify possible ways to strengthen and support Nordic clinical research cooperation through the research ethical review systems, as it is a critical stepping-stone towards a common Nordic clinical research area.
Speakers of the day included Stuart Gander, Managing Director of at the Boston Consulting Group in Stockholm, Marjut Salokannel, legal expert, Jacob Hølen, Director at the National Committee for Medical and Health Research Ethics, Joakim Dillner, Director BBMRI.se and Professor Anders Ekbom, Karolinska Institutet.
Transforming the next wave of success
After opening words from NordForsk director, Gunnel Gustafsson, Stuart Gander took to the stage for the lead speech with his topic: the Nordic Agenda – Transforming the next wave of success.
Gander stated that the Nordics are among the wealthiest and happiest countries in the world, but claimed that the brightness of these “Northern lights” are dimming and the Nordic competiveness is increasingly becoming an illusion when comparing ourselves with key trade competitors.
“The need to transform is indisputable for all Nordic countries if they wish to continue to grow and create wealth in the ever faster-turning world. The Nordics must regain the uniqueness, diversity and competiveness of our exports, increase productivity growth, invest more in the future instead of spending most of the Nordic public expenditure on social protection, and address the workforce gap that the aging Nordic population will create,” said Gander.
Status report
Nordic Trial Alliance is a three-year pilot project designed to make it easier to carry out clinical research in the Nordic countries and project leader Pierre Lafolie gave an enthusiastic talk on the project’s goals and explaining NTA’s efforts in achieving them.
“Strengthening cooperation in Nordic clinical research and research infrastructures by establishing a platform for cooperation is just one of the measures aimed at increasing the number of clinical studies in the region. 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”, Lafolie stated from stage.
Harmonised decisions
Marjut Salokannel indicated a possibility for a common Nordic research area by mutual recognition of research ethical reviews and continued by giving a legal perspective on ethical review and the new EU legal regulation for clinical trials, before Jacob Hølen took over. He talked about shared Nordic values in research and emphasised the benefits of a common Nordic ethical review system with one Nordic ethical review committee taking on Nordic projects.
“A common Nordic ethical system would send a strong message to the world: the Nordic countries are one region. In addition, it is a cost effective solution that will assess many applications, build more experience and competence, and secure equality, independence and harmonised decisions”, he claimed.
However, Hølen ended his talk by stating that it would only be possible to create such a system if the countries existing national Regional Ethical review Committees (RECs) are loyal and accepts the Nordic committee’s decisions, sanction them as their own, and forward the conclusions to the EU portal, as such boards will not without major legal revisions in all Nordic countries have a legal ground on its own.
In the latter part of the programme, Joakim Dillner and Anders Ekbom shared lessons learned from their experiences with Nordic research collaboration, respectively from the Nordic Colon Cancer project and the NorPEN Register project, realising that collaborative Nordic clinical research is much hindered by today’s national regulations.
Before Pierre Lafolie summarised the day and the way forward for NTA, a panel discussion led by Professor Mika Scheinin with the speakers, Morten Andersen and Kristján Erlendsson took place. This discussion commented the hurdles and possible ways forward.
More than 80 people attended the meeting and participants represented research in biobanks, health registers, epidemiology, clinical intervention studies and ethics. Also represented were the pharmaceutical industry, research policy, research funders and government authorities.