CIHR launches major phase of SPOR with $150 million increase to clinical research

By Debbie Lawes

The Canadian Institutes of Health Research (CIHR) has launched the first plank in an ambitious new strategy to fundamentally transform how Canada translates the billions of dollars invested in medical research over the past decade into better outcomes for patients, new commercial technologies and cost savings for cash-strapped provincial governments. If all goes according to plan, it should also provide Canada with a unique competitive edge over low-cost countries like China and India in attracting more clinical trials to Canada.

The first initiative — announced as part of CIHR's Strategy for Patient-Oriented Research (SPOR) — will see both the granting council and Canada's Research-Based Pharmaceutical Companies each contribute $75 million more over five years to a renewed CIHR/Rx&D Collaborative Research Program. The new funding effectively doubles the program's annual budget from $30 million to $60 million, or $300 million over five years.

"What has to be clear here is that we are not taking money from the open grants competition envelope," says CIHR president Dr Alain Beaudet. Shifting funding from discovery-based research to more targeted research is an ongoing concern of many academic researchers who have seen CIHR's funding for open grants drop from 91% to 67% over the past decade, while funding for strategic initiatives increased from 9% to 33%. (R$, March 15, 2012)

Under SPOR, CIHR is consolidating its targeted programs and initiatives that support clinical research. Funding for both SPOR and the CIHR/Rx&D agreement will come from a $15-million boost to the agency's 2011-12 base budget, potential future budget increases and funding from some sunsetting programs (see box). "The SPOR budget is becoming an increasingly large chunk of our strategic budget," he says.

Rx&D first signed on as a partner in 1993 with CIHR's predecessor, the Medical Research Council. Over the next six years, MRC invested $40 million in the agreement, with industry contributing an additional $200 million. The program was re-born in 1999 under a new agreement with CIHR.

Since then, CIHR and Rx&D have provided millions to support research training and salary support (fellowships and research chairs) and research grants (operating grants, clinical trials and workshops) that are supported by industry. But there was no single priority to guide those investments and Beaudet says the agreement hasn't been as "transformative" as it could be.

"Some projects have been investigator-driven, others have been more top-down strategic and others with third partners," says Beaudet. "It was a bit of a dog's breakfast."

That will change under the latest agreement as CIHR begins to shift more of its strategic spending to patient-oriented research, including improving regional capacity to support industry-led clinical trials. Despite strong expertise in this area, Canada continues to lose ground globally, with the number of clinical trials and trial sites dropping by about 30% between 2006 and 2010.

"There's a certain amount of global R&D dollars available, and by focusing on that space we are making Canada competitive to attract those inward investments," says Dr Ken Hughes, Rx&D's VP, scientific & regulatory affairs. "So, you're looking at optimizing the clinical trial process and dovetailing that with biomarkers which are relevant to disease states of the day… it's anything from bench to bedside and back. It has to be oriented towards the patient."

Competing with India and China on cost isn't realistic, Beaudet admits, which is why the SPOR will focus on Canada's other strengths, including systematic reviews, ethical reviews, large government-controlled clinical databases and a skilled workforce.

"Where we have to improve is on structure, effectiveness, speed of ethical reviews, speed of contracting and speed of recruitment (of patients to trials). These are all areas that we recognize have weaknesses in this country," says Beaudet.

Pharma companies often have to negotiate ethics approvals with individual hospitals and separate contracts with each province, which makes multi-site clinical trials cumbersome and more expensive. CIHR recently developed a contract template that can be used across provinces.

New national networks and SUPPORT units

Released last August, the SPOR was developed by CIHR in collaboration with provincial/territorial governments, health charities, academic healthcare organizations, faculties of medicine and industry. The strategy represents a fundamental shift in how applied medical research is funded and conducted in Canada, from an investigator-driven model to one that is focused on better outcomes for the patient.

It is part of a larger corporate-wide effort to improve the quality and outcomes from research. CIHR is also reforming how it categorizes and adjudicates grant applications citing the need to reduce complexity and time required for researchers to participate in competitions. (R$, March 15/12)

SPOR, meanwhile, is tackling the two "Valleys of Death" in health research: the poor track record in translating basic research into new treatments and commercial products; and, limited capacity to integrate these results into clinical practice and decision-making. This failure has contributed to skyrocketing healthcare costs.

"The biggest problem for the provinces is containing the health costs and some of that will come through research," says Dr Robert McMaster, VP research, Vancouver Coastal Health and a member of the SPOR national steering committee.

The strategy will begin rolling out this year, including steps to address a shortage of biostatisticians, health economists, clinical epidemiologists and social scientists focused on clinical research. Also critical is the need for non-clinical research personnel and support staff such as trained project coordinators and research assistants. Addressing the training gaps will help clinical researchers better juggle the competing demands of teaching and research.

"Clinical investigators find that their research commitment is increasingly difficult to pursue, as many are overwhelmed by clinical and teaching duties, often as a result of growing shortages of health care professionals in their particular fields," CIHR said in a written response to RE$EARCH MONEY.

Under SPOR, CIHR is holding competitions this year for two clinical research networks focused on community-based primary health care and mental health. The networks will receive $25 million over five years with half coming from CIHR and the remainder coming from partners. Pharmaceutical companies would then tap into these networks to conduct multi-centre clinical trials in priority areas identified by CIHR.

"Cancer professionals are also interested in a network and are already starting to work on a proposal. Child health is also interested. It's thought there may be six networks supported from this initiative," says McMaster.

The pan-Canadian networks will be linked to provincial SUPPORT (Support for People and Patient-Oriented Research and Trials) units, which would have the resources and personnel needed to conduct research. Funding levels still to be decided, with one proposal suggesting a formula based on $1 per resident in a province. Funding would come from multiple partners, including CIHR.

A group representing Nova Scotia, New Brunswick and Prince Edward Island has been working for several months on its proposal for a SUPPORT unit that would include medical faculties, departments of health and medical institutions. "We're going to focus mostly on data sharing and data management," explains Dr Raymond LeBlanc, VP research and innovation, Capital District Health Authority in Halifax. "Like many others we have tons of small databases: surveillance, health outcomes, administrative. But they all reside in different places, are not necessarily easily accessible by people who need them…and they don't cross provincial boundaries."

HAVING PROVINCES "CALL THE SHOTS"

Provincial governments will be key partners in implementing the strategy, although budget cuts this year and likely beyond may preclude them from putting significant cash on the table. For example, the Nova Scotia Health Research Foundation's annual grant from the province has been stagnant at $4.9 million for the past two years.

"A significant ask for matching dollars from the province is something we're concerned about, which is why the departments of health and wellness of the three provinces have been at the table," says LeBlanc. "The whole strategy is for them to understand not only how important this is but how it will solve some of their problems."

Despite the funding challenges, Beaudet says the provinces have to be major players in the clinical research networks and SUPPORT units for SPOR to have any effect.

"What we're moving towards is really having the provinces call the shots: establish the needs they have, come up with their plan, come up with their proposed structure, their priorities ... We would match the money the provinces put on the table within a previously defined limit that the steering committee will agree on that is reasonable within the framework of our budget."

While more funding will undoubtedly be needed, McMaster says the real success of SPOR will depend on close collaboration between the various partners. "By working together we can share and build common resources and work towards the same goals. More money won't necessary give us more successes. It's the partnerships that are key."

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