Across the country, scientists are making important discoveries in the lab. Unfortunately, however, many of them won’t make it into the clinic. Canada does not have the innovative environment to translate discoveries made in test tubes or animal studies (also known as basic science) into treatments and technologies in health care.
This is reflected by Canada’s low ranking in the innovation analyses conducted by the Conference Board of Canada, an independent organization. Canada ranks a demoralizing 13th of 16 comparable countries.
We are pleased to see that the current government is interested in addressing the problem. In March, the Trudeau Government announced that it will increase the Canadian Institutes of Health Research (CIHR) budget by $22.9 million/year and invest $800 million over four years to support innovation networks. The current Minister of Health, the Honourable Jane Philpott, wants to support “patient-oriented health research and translational medicine through increased investments.”
However, the government hasn’t outlined how it plans to spend the $800 million. It is not clear what percentage of this budget will go to health research, and what percentage of that will be directed to the first stage of translational health research. In Stage 1 of translational research, scientists use the knowledge gained in basic science research to develop a tangible health product, and to test the developed health product in humans. Governments and industry are generally reluctant to invest in basic science and Stage 1 research because it can take 10 to 17 years to see a return on investment. Instead, public and private investors prefer to fund Stage 2 research, in which an already-developed health product is introduced into the clinic. Both basic science and Stage 2 translational research are important for health innovation, and the Trudeau Government should fund projects in both of these areas. However, we firmly believe that a significant portion of the innovation fund as well as CIHR’s budget needs to be used to alleviate the barriers present in Stage 1 of translational research before the Trudeau Government’s innovative vision can be fulfilled. There are several other ways that federal and provincial governments can bolster translational research.
Support new funding models
The unpredictability and costs associated with Stage 1 translational research often discourages private investors. For example, it costs almost $1.7 billion for a drug to be discovered and tested, but only 11% of drugs that enter clinical testing will ever be approved by the FDA. The Canadian government can do more to help incentivize private venture capitalists to invest in these high-risk ventures. Canada can look to innovative funding models like the Israeli government’s technology incubator programs to facilitate private investment. Launched in 1991, the program subsidizes up to 50% of start-up firms’ R&D costs and provides lucrative incentives for private investors. Initially, the incubator program heavily depended on public funds, but as the program matured, private funds outnumbered public funds by six times, highlighting the ability of this program to attract industry. Similarly, Canada should invest money into incubator programs such as the H2i Health Innovation Hub – an initiative launched through the University of Toronto to support the translation of students’ ideas and discoveries into practical applications.
Historically, there has been a distinct divide between academia and industry, with differing perspectives and little interaction. The priorities of each are different: industry is closely tied to economic success, while academia is focused largely on the scientific process of discoveries. Nussbaumer and Klebl suggest that industry and academia should collaborate at the onset of development, to reconcile this divide early on. They recommend translational research centres that foster collaboration between academics and companies – to ensure pursuits that are both scientifically important and economically viable. Concentrated efforts have been made in other countries to create such centres. For example, Germany’s Fraunhofer Society has created a closer link between academia and industry through funding online networks, as well asbuildings that house offices, labs, and shared spaces for companies and scientists. Toronto has a similar centre – the Medical and Related Sciences (MaRS) Innovation. However, its network is far from as diverse or large, with 18 research institutes in Ontario, compared to the Fraunhofer’s 67 research institutes spread across Germany.
Jumpstart Clinical Trials
Clinical trials must be performed before translating a health innovation into the clinic. The most recent analysis conducted by the Canadian Institute of Health Research (CIHR) showed that the number its applications for clinical trial funding declined by 24% from 2006 to 2010. CIHR attributed this trend to barriers such as: 1) each hospital having their own ethics review boards, each with their own requirements, making it very inefficient for ethics approval to be granted; 2) difficulties in patient recruitment; and 3) the absence of a legal network to address issues such as consent forms and intellectual property protection. To improve the clinical trial infrastructure, the Trudeau Government should fund the Clinical Trials Coordination Centre initiative that was established by the CIHR so that its action plan can be implemented. The proposed action plan aims to, among other goals, coordinate patient recruitment and help researchers more quickly implement studies. It would also streamline the ethics review process, by developing a Pan-Canadian accreditation system for Research Ethics Boards.
The Centre’s action plan is similar to the Clinical Trials Office in Denmark, which provides assistance to researchers in identifying sites and investigators that can perform clinical trials, as well as navigating legal issues. After the establishment of the Clinical Trials Office in 2012, the number of clinical trial applications in Denmark went up by 14%, from 2012 to 2013.
Invest in Training
The complicated nature of the health innovation pipeline requires individuals who are trained in both medicine and basic science so that they can bridge the gap between the two. Furthermore, these individuals also require an understanding of project management to manage multi-disciplinary research teams and regulatory affairs. Unfortunately, due to budget pressures, CIHR recently cancelled its funding for students in combined MD/PhD programs, a program that trains such individuals. Conversely, the German Federal Ministry of Education and Research continues to expand its support for clinician-scientist programs, and training in areas throughout the translational pathway including project management and regulatory affairs. Canada needs to affirm its commitment to training healthcare professionals to be competent in translational research. A good start would be re-instituting funding to the MD/PHD programs.
In summary, by improving translational research funding, facilitating academia-industry partnerships, and training individuals who are equipped to advance the innovation pipeline, the Canadian Government’s vision of improving health research can be fulfilled. Canada can become a leader in translational research – but funding alone won’t get us there.