- policy initiatives and trends
The Swedish Agency for Growth Policy Analysis was commissioned by the Ministry of Education and Research to describe certain trends and policy initiatives related to clinical studies, including trials, in Denmark, Belgium, Great Britain, the USA and Canada.
Various reports have shown a decreasing number of clinical trials in several western European countries and an increasing number in eastern Europe and Asia. The trend is credible but seems perhaps to have slowed between 2008 and 2012, possibly as a result of increased costs in eastern Europe and measures to improve conditions, for example in Great Britain.
The trend in Sweden, however, seems to be slightly more negative than in Belgium, Denmark and Great Britain. In Sweden, the number of trials in phases I to IV decreased by 24-28% (according to the clinicaltrials.gov database). A positive trend can on the other hand be seen in the case of observational studies in Sweden and in several other European countries. Short time series, large annual variations, relatively poor quality databases and dependence on the general economic climate constitute difficulties as regards a reliable interpretation of how this development is proceeding.
As a consequence of this development, several countries have felt obliged to change their system for clinical studies, which are important, not only for financial reasons but also since they are a crucial part of their ability to translate¹ biomedical research and can contribute to positive development within the field of health care, for example speed up introduction of new forms of treatment and access to new pharmaceuticals. The measures initiated can in most cases be grouped into the following areas:
- Collaborations on research and innovation between funding providers, care organisations, universities, charitable organisations and companies. These collaborations aim to increase translation, increase interaction and create a more integrated ecosystem for research and innovation (R&I) in the life sciences.
- Recruitment of and access to patients, for example through clinical research networks, information portals and the build-up of accessible patient cohorts.
- Measures to improve the research and innovation culture in the care system.
- Greater transparency, for example through broad dissemination of information about trials.
- Simplified and accelerated procedures for issuing licences, ethical reviews and access to resources in the care system.
- Information initiatives, including innovative ways of using information from the care system.
- International marketing.
- Improved cost-effectiveness and quality awareness.
The analyses indicate that it is not necessarily lower costs that are most important when it comes to attracting clinical trials. People who have been interviewed have pointed out the importance of cost-effectiveness, quality, punctuality, good opportunities for collaboration and access to well-characterised patients as central factors in decisions on location. At the same time, the decisions are obviously influenced by the kind of trials in question and by new ways, for example more Contract Research Organizations (CROs), of conducting trials.
Denmark and Great Britain seem to have come a relatively long way in their measures to attract trials, which British experts consider are already having positive effects. In Belgium, which has a long tradition of clinical trials, such measures are largely still at the planning stage, but the discussion is similar to the ones going in Denmark and Great Britain.
The USA still dominates clinical studies, although the number of trials in phases I to IV has fallen in recent years (2008–2012), albeit from a very high level, and the USA will undoubtedly continue in the lead for the foreseeable future. The main thrust of the American measures is to stimulate translation and change the regulatory prerequisites for pharmaceutical development, including trials. Many people in Canada consider Great Britain’s reforms in the field of life sciences to be an interesting model. In Canada the plan is now to increase initiatives aimed at translation and improve the prerequisites for clinical studies. In China, the number of clinical studies is increasing rapidly, but from a low level.
Several of the countries studied, and others, are working pro-actively to improve the conditions for clinical studies, which Sweden needs to consider. Regardless of what measures Sweden adopts in the short term, an iterative process is probably also needed to develop the long-term conditions for types of trials where Sweden can be particularly competitive. These might for example include trials on well-characterised patient populations, studies where collaboration with internationally competitive research and innovation is of considerable importance, and studies where Sweden’s advantages in informatics and registers contribute added value. At the same time, the general regulatory framework for trials probably needs to be strengthened in several areas. A further question is whether deeper collaboration on clinical trials between the Nordic countries might be desirable in the long term, for example regarding identifiable patient populations and recruitment of test subjects.
¹ By translation is meant the bilateral flow of knowledge and findings between basic research, clinical research, innovation and care.