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Applied Clinical Trials
The European Union has a new research program, but will it help, or hinder, clinical trials?
Horizon 2020—the European Union's newly-agreed seven-year multi-billion research program is one of the few areas of the EU's new budget that sees a major increase in resource—roughly 30% up on its predecessor program. And according to the triumphant announcement of the commissioner, "Horizon 2020 will fund not just the best fundamental research, but also applied research and innovation, bringing in small and large companies."
For those interested in clinical trials, the most interesting elements of this vast program are doubtless within the public/private partnership on innovative medicines, and on aging populations, poverty-related diseases, and support for smaller firms. The EU insists that it is keen on helping smaller firms' research and innovation. The commissioner cites new financing options in the form of risk-sharing through guarantees or risk finance through loans and equity to support innovative companies.
At the heart of the drug development element of the program is IMI2—the follow-up to the Innovative Medicines Initiative that has seen industry and the EU working together for the last seven years in a $2.5 billion joint sponsorship of early-stage research. Horizon 2020 envisages an expansion of this public-private exercise under IMI2, and the approach has won support from industry and from national governments. The EU has moved ahead of the necessary full endorsement of the plans by giving notice that it will offer research grants of more than $1 billion for drug-related research early in 2014, ranging across therapeutic categories, technologies, and disciplines.
Under the umbrella title of personalizing health and care, nearly $500 million is promised for projects in advanced therapies, new diagnostic tools and technologies, predictive human safety testing, pediatric treatments, and improving understanding of disease through systems medicine and investigation of common mechanisms of diseases and co-morbidities. There is further support available for personalized medicine development under another package, part of which will be devoted to translating 'omics' into stratified approaches to advance health promotion and disease prevention, and part to screening and prevention programs, new in vitro diagnostic tools and assays, and new models for efficient prevention-oriented health systems. A further $200 million is slated to fund clinical research on regenerative medicine, and vaccine development for HIV/AIDS. The funds will also go to wider use of information technology in early risk detection and intervention; integrated care and patient self-management; eHealth services; and improved diagnosis and treatment.
The lead committee in the parliament will introduce both general and specific limitations to IMI2. IMI2 "should not fund all clinical trials, but only those which have an innovative turn to them." And it wants to intervene in the definition of acceptable research. "Those partnerships should reflect a balanced contribution from all partners, be accountable for the achievement of their targets, and be aligned with the EU's strategic goals relating to research, development and innovation. The governance and functioning of those partnerships should be open, transparent, effective, and efficient, and give the opportunity to a wide range of stakeholders active in the specific areas of those partnerships to participate."
The parliament also wants to trammel the process with additional criteria—"in particular, principles on gender equality and open access," among others. Some members of the parliament are urging that the program's priorities shift from therapy and towards prevention, and that no support should be given to clinical trials beyond Phase II.
In advance of the committee vote in late January, the European Alliance for Personalized Medicine (EAPM) came out with a detailed statement strongly supporting "the IMI2 contribution to achieving the goal of personalized/stratified medicine across the EU." IMI2 is "a key EU initiative that can...bring about a balanced and added-value reworking of the R&D cycle. But limiting the activities in the IMI2 proposal, in particular clinical research, will seriously stall the development of lifesaving treatments."
In particular, EAPM says amendments calling for a ban on Phase III and IV trials "are too extreme and would jeopardize the ability of IMI2 to deliver innovative research, development prevention and treatment solutions for critically ill patients." It points out that in the area of rare diseases, for example, late-stage R&D carries a high risk of failure, and the EU should therefore provide real incentives to all parts of the research community, in particular academics and smaller firms, to participate. EAPM believes it is crucial to attract outside investment to Europe-led projects.
Before the debate moves on to its final stages in February, other similar warnings and admonitions are likely to emerge from other researchers. Many of the proposed amendments are well-intentioned and match Europe's cautious zeitgeist in relation to research. But too much well-meaning interventionism has repeatedly handicapped Europe's bid to create an environment conducive to research, and the brave new world that EU rhetoric is promising is at risk of being reduced to a timid old formula of excessive intrusion.