The Nordic Trial Alliance initiated project – Collaboration between Industry and Academia, held a conference in Helsinki 22 – 23 April 2015. The conference showcased the opportunities, possibilities and advantages that exist in the Nordic region for clinical research. Each country presented strategies and initiatives from government level, specific projects undertaken at hospitals and universities, and distinctive resources and platforms for clinical research. The delegates represented academia, hospitals, industry and governmental bodies from all over the Nordic area and both challenges and possibilities were discussed.
One of the arguments against conducting clinical research in a single Nordic country is that there are too few patients there. Countries with approximately 5 million inhabitants face fierce competition with nearby countries with up to 80 million inhabitants. The only way to cross that gap is to collaborate.
-As long as your countries try to compete as a 5-10 million country with countries with a lot larger population, you will notice it is difficult. Size matters, not from a commercial point of view, but from a patient recruiting point of view. If you want to get out of that trap you need to act as one region, Dr. Hassan Ansari, Associate VP & Head Global Operation, Europe, Merck (MSD) said during the conference.
-From the industrial side it is important to create environments where the contracting procedure is transparent and fluid. There should be a partner on the other side, so we don’t have to start the machinery every time we propose a clinical study. The hospitals and academia should secure that they have their engine running, even in idle mode when needed, and that it can be used. We are also dependent on doctors allocating time for the clinical study we have contracted. This allocation of time is impossible to make at 8 pm (20.00) after already a full day of doctors work, said Dr. Ansari.
– Our company, and I guess all the others, are willing to pay for time we need for the clinical study, but the hospital management must secure that the money are re-invested and allocated where they are needed, so the doctors can allocate their time, he added.
Dr. Ansari also added that it does not matter if the Nordic countries are high cost countries, as long as the delivery of clinical data from the contracted study is of high quality. The industry need both study performance and data delivery of high quality. It is also important to recruit the patients within the time limits agreed upon in the contract.
The five Nordic countries have good prerequisites for collaboration partners. They all have democracies, they have health systems that are distributed and covered by tax system and not by fees, there are excellent registries and biobanks in all countries, and there is a great potential for clinical research, both from an industrial and an academic perspective.
The bottlenecks we have when it comes to health registries and biobanks are to a large extent legal. Our countries laws have not been adapted to a global situation, where communications is 24/7. We need exchange of data across Nordic borders if we shall prevail, said Professor Aarno Palotie from the University of Helsinki. He got support from many in the auditorium who expressed that the advantage with our biobanks and registries on a Nordic level has been down-regulated by the legal systems. A Nordic collaborative approach on laws and regulations, would have given all Nordic countries big global advantages. Gun Peggy Knudsen at Folkhälsoinstitutet in Norway confirmed that this as a problem.
-We see many rejections from the ethical review boards (EC) when we want to link the registries. We have a very demanding regulation, and we can see that it is easier to get approval in the other Nordic countries.
One proposal that was launched at the conference was that the Nordic countries could have a common Nordic ethical review board, who’s decision would be accepted and have the same definition in all countries. A problem recognized by the industry today is precisely this, that a proposed clinical study can be completely rejected in one country – while accepted in another.
-In the industry we are very delighted over all your registries and the data you have, but we can’t use them as long as we can’t access the data. We need often broad approaches for a registry search, but this is often not approved. As it is today, the laws and regulations you have halter the development of new medicines to the benefit of the patients. This is the real problem, said Dr. Ansari.
Stener Kvinnsland from Bergen asked for better collaboration in oncological trials where development implies smaller and smaller proportions of patients due to genetic understanding of the disease, leaving fewer patients in each country. Free flow of protocol across borders, and moving patients across the borders could be part of the solution, including better harmonization of ethical demands between the Nordic countries.
Gertrud Rex Baungard, Danish Ministry of Health, presented the Danish plan for strengthening clinical research in Denmark, the Danish National Forum for Collaboration on Health Research. This includes both Ministry of Research and Ministry of Health, the Danish regions, the industry, universities, and Danish Health and Medicine Authority. STARS (strategic alliance for register and health data) together with Clinical Trials Office Denmark, will support this development, as a response to EU Regulations. There will be one entry point for access to national health care registries and the National Biobank. The plan includes 10 concrete initiatives, including the NEXT model (see below).
Liisa-Maria Voipio-Pulkki, Chief Medical Officer in Finland, reported on a new strategy in Finland to attract more clinical studies based on more collaboration at the ministerial level, including employment, business / social affairs, welfare and research, and education. This horizontal approach grants a more holistic view avoiding silos which reduce output.
Ingrid Petterson, Director General of the The Swedish Research Council FORMAS spoke about her report to the Swedish government called “Strong Together”. This investigation found that fewer patients and more complex trials resulting in a loss of clinical research for the country. The final proposal included new business models, easier feasibility testing, prompt processes and better incentives at all levels. The program is now under implementation in Sweden.
Maiken Engelstad, Deputy Director General at the Ministry of Health and Care Services in Norway presented the plan “Health&Care21”. This program includes the national research and innovation strategy 2014 and outlines activities in science and health. The key to growth and renewal is to improve the operating environment of the ecosystem in which clinical trials thrives. This includes support to competence, research infrastructures, networks across industries, public and private research, demand driven innovation, investing in exports, and funding R&D activities. She also mentioned the need for a Nordic common model to be able to compete with the large countries, a model where Nordic Trial Alliance is needed.
In the following panel discussion the question arose if the Nordics are too competitive? The answer was that the countries need to organize themselves, that the on-going national initiatives can open for more collaboration. Collaboration can be found easier in certain areas, e.g. the ethical review board system. – No other global region combines the discussion on health with industrial perspectives as you do. You should realize that you are all democratic states who shares common ethical values. You are in the pole position to create a value chain including hospitals, academy and industry. We need a Nordic agreement, now, Dr. Ansari said.