Canadian government launches massive overhaul of clinical research process to create infrastructure
The Canadian Institutes of Health Research (CIHR)—the federal government’s health research investment agency—is undertaking a massive overhaul of how clinical research is conducted, attempting to align large sites and other parties in all provinces to create an integrated research infrastructure.
As part of the effort CIHR is developing a national ethics organization, as well as a master contract for pharmaceutical companies to use with Canadian researchers.
It’s a colossal job, but necessary to advance the clinical research industry in Canada and bring new treatments to patients there, said Jean Rouleau, scientific director of the CIHR’s Institute for Circulatory and Respiratory Health.
“We’ve been very successful in getting research going in Canada, but could use more work in patient-oriented research, bringing discoveries to clinical care,” said Rouleau, dean of the University of Montreal’s Faculty of Medicine, and cardiologist at the Montreal Heart Institute. “We need to upgrade and render efficient more of our clinical research machine.”
The key, he said, is in the individual provinces taking the lead in getting various stakeholders on board. Those include academic medical institutions, other investigative sites, hospitals, charities, the private sector and health-related agencies. The CIHR is helping each province develop “support units”—basically better infrastructure to support clinical research, and a central hub for pharma companies and others to tap into when seeking to conduct research in that province.
“When we look to the future, we see better alignment among all parties involved in research, aided by multi-disciplinary support groups developed in each province,” said Rouleau.
Rx&D, an association of pharmaceutical companies and their employees working in Canada, has pledged $150 million over five years to the effort. Rouleau said he hopes other grants will be in place and funding the proposed support units by May 2013. The effort will be partially funded by the CIHR with the hope that matching funds will be contributed by the various partners.
Part of the effort involves training people in areas needed to make research more robust in Canada, said Rouleau, explaining that biostatisticians are badly needed, as are more principal investigators. But just how many of each exist in Canada now is unknown. Creating those metrics will be an early focus of the overhaul, he said. “We’re working with the partners to figure that out,” he said.
Also key will be the new national ethics organization, which Rouleau said will be modeled after the British system, with each province having “alpha ethics centers” whose evaluations of a trial would be recognized by other provinces in which the trial is being conducted. Those provinces also would have the option to not accept the evaluation of another province’s alpha ethics center and instead render their own, he added.
The concept is underway in the various provinces but moving “at different speeds,” said Rouleau, adding that the alpha or super ethics centers are being established at academic health centers. Currently, there’s no communication or alignment between IRBs in any of the provinces. Commercial IRBs exist in Canada, but they are not being considered as possible ethics centers, he added.
Contracts are a large area of focus, too. Last month, after a year of negotiations, CIHR reached an agreement with Rx&D for a common template its members will use when contracting with Canadian sites to conduct research. Problems with contracts have been “plaguing researchers in Canada forever, and making us much less efficient,” Rouleau said.
Embracing adaptive trials and other new methodologies might also become a cornerstone of the new effort. Rouleau said the CIHR is funding a meeting with the initiative’s major partners to discuss the concepts next spring.
If everyone buys in, said Rouleau, the huge initiative could transform clinical research in the country. “It’s a truly Canadian approach, where it’s not going to work unless our partners agree and are enthusiastic going into it,” he said. “As opposed to many of the other initiatives ongoing in the U.K., the U.S. or Europe, its success is totally dependent on alignment of all the various stakeholders, which makes things more complex. We’ve gotten partners from coast to coast to agree on how we’re going to go about this. Now operationalizing is the challenge.”
Will it all come together? Said Rouleau, “I would risk saying that I’d be surprised if it didn’t.”