More than $320 million over five years

The Canadian Institutes of Health Research (CIHR) is set to launch a major new component to its emerging commercialization strategy with an agreement in principle to partner with the Canada Foundation for Innovation (CFI) on a clinical trials research program. Designed to capitalize on Canada’s strong health research base and centralized health care system, the proposed Clinical Research Initiative (CRI) could see more than $320 million over the next five fiscal years injected into clinical research trials and platforms, marking the first time CFI has collaborated with another agency on such a large scale.

CFI will devote at least $100 million in infrastructure support from its $500-million Research Hospital Fund covering 40% of successful project costs, with the remaining 60% of the infrastructure costs covered by provincial governments, the private sector and the applying institutions themselves. It’s anticipated that CIHR will commit $70 million to the collaborative program to support operational, salary and training support. With that kind of funding, its backers are confident that the CRI can have a major impact on boosting both the social and economic benefits arising from health research.

“This provides a major opportunity to transform clinical research and how we commercialize research in this country,” says CIHR president Dr Alan Bernstein. “We need new companies in Canada but we also need a very robust clinical research infrastructure. Other countries have recognized this and we have been consulting for years about launching a major initiative of this kind.”

For the CFI, the CRI marks the first major collaboration to emerge from a new strategy to increase formal interaction with Canada’s three granting agencies. With nearly $450 million left in its RHF, the CRI offers a potent vehicle for increasing the outputs from health research while streamlining the application process for successful projects.

“We have a tremendous opportunity in Canada because of our health care system which is more centralized than in other countries. One of my objectives is to work more effectively with the granting councils and the research community. This program could provide one-stop-shopping and avoid duplication,” says CFI president Dr Eliot Phillipson. “There’s knowledge out there that is ready to be translated into clinical advances … The health care system is a great social program but it can also be a great economic program. We can devise better health care products and delivery systems that are marketable.”

TWO PROGRAM MODELS CONSIDERED

Tentatively entitled the National/Regional Clinical Research Initiative, the CRI is being spearheaded by Bruce McMannus, scientific director of CIHR’s Institute of Circulatory and Respiratory Health. Its genesis is found in a report — the Multi Stakeholder Task Force Report — headed up by Dr John Cairns, dean of medicine at the Univ of British Columbia. Although still at the design stage, two models are emerging as possible programs.

The first would establish a series of clinical research centres spread across the country but linked to establish common protocol and providing sufficient numbers for clinical trials. The centres would involve actual patients for the purposes of conducting biological clinical studies. CFI would support the physical infrastructure while CIHR would be responsible for supporting long-term operating costs, associated research training and salary support for clinician-researchers who would act as mentors for training.

The second potential model calls for the creation of technical research platforms. These could be databases derived from patients and stored centrally, or they could be DNA, tissue or tumour banks used by researchers proposing specific studies.

“We want to translate research into clinical medicine and these centres are the venues where that translation occurs,” says Phillipson. “I see it as a continuum from more basic research through to translation.”

A draft call for proposals (CFP) will be issued later this summer or in the early fall to gather feedback on the proposed program. In November, an official CFP is anticipated.

The CRI represents the largest single amount of public funding ever devoted to clinical research trials. But it is just one of three programs targeting clinical research approved by CIHR following a two-year-long consultation process. In addition to CRI, CIHR is planning a new program to support mid-career clinician researchers while boosting funding for existing career support programs.

Also on the books is a program to provide operating grant support for clinician researchers. The latter is on hold pending an increase to CIHR’s overall budget.

Budget limitations are also restricting CIHR from making a larger commitment to CRI. Under the current proposed scenario, the CFI-CIHR program will be able to fund six clinical research centres and four technical platforms.

“Clinical research trials are very expensive but there’s a big payback,” says Dr Mark Bisby, CIHR’s VP research, adding that the opportunity to collaborate with CFI’s through its RHF was a timely coincidence. “We’re trying something unprecedented but what we can afford to do at this time is a bare-bones approach. If we get more funding, we will be able to increase contributions to the program.”

LINKED TO CIHR COMMERCIALIZATION STRATEGY

The proposed CRI comes at a time when CIHR is rolling out a multifaceted commercialization strategy aimed at moving knowledge into the health care system and the economy (see page 4). Bisby says that while CRI is not an explicit part of the strategy, there are strong correlations.

“The whole thrust of infrastructure is to try and fix the bench-to-bedside approach and it can lead to the development of better products and services,” he says. “It could also lead to more clinical trials. Canada has excellent trials but our share of trials conducted by large pharmaceutical companies is falling.”

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