Potential and challenges in coordination of clinical trials
Lessons from England, USA and Denmark
This report captures lessons from England, USA and Denmark, with regards to governance, coordination and improvement of national conditions for clinical trials. The text takes a point of departure in “Starka Tillsammans” (SOU 2013:87), on the one hand, and in country reports on the same theme previously published by the Swedish Agency for Growth Policy Analysis, on the other.¹ The following conclusions and recommendations are aimed mainly at the building of a national coordination function for clinical studies in Gothenburg.
Four different national contexts facing the same basic challenges
Overall, Sweden and the countries studied in this report have a lot in common. All share a traditionally strong position within the life sciences in general, and for clinical studies in particular. On the flip side of this coin, all countries have also been characterised by weak transformation pressure – high profit margins and weak competition have over time resulted in a lack of cost awareness and process innovation. Due to several recent changes, particularly in the last decade, the pressure is now mounting. The costs involved in developing new drugs and treatments have risen sharply. The probability of success in developing new products has decreased. Global competition is getting stronger. The main driver of basic research – the public research funding system – as well as the public health care sector, which constitutes an important test environment and market for new drugs and treatments, now face severe resource cuts in the wake of the deepest and longest financial crisis since the 1930s’. The private sector has also been hit hard by the financial crisis and venture capital has partly abandoned the life sciences for safer industries with shorter product development times. In short, the life science sector is under pressure from all directions, which may result in severe negative impact to public health (as industry abandons entire treatment areas) and economic growth.
The international lessons captured in this report point out two common drivers and two general challenges. Good national conditions for clinical trials benefit both: (i) public health, and (ii) economic growth. The main mechanism is that more and better treatments reach patients quicker and meet healthcare needs faster – not just nationally, but in international markets as well. At the present time, however, the road from desktop to bedside is: (a) too long and (ii) too risky. A lack in efficiency and precision, combined with increasing development times and development failure risk, lead to unsustainably high costs being transferred onto the healthcare system. Also, it may hinder the healthcare system’s capacity and capabilities from keeping up with the growing demand for healthcare created by changing demographics. In short, these are the common challenges that all countries included in the study are facing, but each national response is formed by specific national conditions.
England – top-down-governance and new government agencies
The English case is marked by a clear top down approach to meeting the abovementioned challenges. A comprehensive analysis ordered by Parliament resulted in the formulation of a national strategy. This strategy, in turn, has been implemented in the form of new government agencies and changes to the governance structure for clinical trials in England. There is consequently a high degree of formal coordination in the design of the national landscape. The English case, however, shows that there is also a need for continuous day to day coordination in the implementation of the national strategy. The reason for this is that there is already a comprehensive system in place, at the start of implementation – and that the actors in this system generally do not have a full picture of why the situation has changed and what needs to be done in order to adapt. In this sense, there is an inherent inertia in the implementation of the national strategy.
The main lesson for the Swedish situation is twofold: on the one hand, the English case, which is years ahead of Sweden in terms of national coordination, is rich in examples of how the public sector in practical terms can play a role in improving the situation for clinical trials; on the other hand, the English case stresses how important continuous efforts and lasting public platforms (i.e. public bodies with explicit and long term mandates to improve the national eco system for clinical trials) are to successful implementation of coordination strategies.
Denmark – bottom-up-solutions inspired by England
Medical research is the single largest research area in Denmark and clinical trials is often described as central, in Danish political discourse, to Danish healthcare, public health, and for innovation and economic growth. Like England and the US, Denmark has also seen a decrease in the number of clinical trials. Initiatives have been put in place to turn this development around. Efforts take a main point of departure in the notion that Denmark could very well be made into a more attractive location for clinical trials despite its relative cost disadvantages, but that policies need to be targeted at specific areas for this to succeed. In particular, the intersection between public and private research is identified as an area of large potential for future development and growth.
Danish policy is largely inspired by the English approach – but, due to the Danish system being significantly smaller in scale, the Danish strategy is to address the problems with a bottom up, rather than a top down, approach. Denmark is divided into five healthcare regions and the national coordination structure is simply made up of five regional coordinators that serve as access points for researchers and industrial actors. In practice, said coordinators collaborate to ensure that they form a national network of patients, researchers and clinics that can be accessed through one single point of contact at the regional level. The network also handles applications for clinical trials and various supporting services to researchers and industry. In many ways, this network of regional coordinators achieves the same national coordination structure that the central reforms have achieved in England, but with a point of departure in the local level.
USA – searching for the future of clinical trials
The US case represents a broad variety of strategies – but one thing sticks out in particular: the focus on making fundamental changes to the logic of clinical trials as we know it. At the highest levels of US governance there is a clear worry that the system is unsustainable in its present form. This seems a reasonable concern given that the US has both the highest average cost for clinical trials, and the highest per capita consumption of healthcare, in the world. The US view is that faster administration and more efficient regulation of clinical trials, which is the focus in England and Denmark, is not enough to solve the problem. Instead, in this view, the overall process for clinical trials needs to be redesigned.
From a Swedish perspective, the US case offers a glimpse into the future – in part with regards to the possible scenario that Sweden may soon end up in the same cost dilemma that the US is currently facing, in part in the sense that the US development is likely to continue to dictate how things are done in Sweden, since it will likely continue to be the dominant market and research arena for this industry. While we have a lot to learn from England in terms of how coordinating bodies can be built and operated in the short term, we have much to learn from the US in terms of the challenges that such bodies will face in the longer term.
¹ Kliniska prövningar – policyinitiativ och trender. Tillväxtanalys, Svar Direkt 2014:01, Vad händer inom Life Sciences internationellt? - Nuläge och trender i utvalda länder. Tillväxtanalys, Svar direkt 2012:05
Potential and challenges in coordination of clinical trials Lessons from England, USA and Denmark
Serial number: PM 2015:09
Reference number: 2014/274