Clinical Research Shouldn't be a Trial: How Ontario is Competing to be the Best Place to Conduct Clinical Trials

A few years ago, a collection of hospital, academic, university, and industry leaders based in Ontario, Canada convened to discuss a disturbing trend: the province was seeing a marked reduction in the number of clinical trials, despite the fact that the province had long been a preferred location for clinical research.

Competitiveness in the field of industry-sponsored clinical research is largely contingent on speed, quality, and cost. While historically a strong competitor with respect to clinical trial investment, Ontario had been facing escalating competition from generous tax and subsidy regimes in developed nations as well as rapidly increasing clinical trial capacity and quality in low-cost emerging economies. The province knew that in order to stop the decline, it needed to act quickly and collaboratively with its stakeholders.  As Ontario is widely recognized as a jurisdiction that generates high-quality data, the province determined that the greatest gains in competitiveness could be achieved by making structural changes to improve speed and efficiency, while sustaining quality, at the same or reduced costs.

The answer came in the form of a new public-private consortium, Clinical Trials Ontario, launched in July 2012. Clinical Trials Ontario brings together six partner organizations from academic research and private industry to collaborate in making Ontario a competitive and attractive environment for clinical research.

Clinical Trials Ontario has three key priorities: cut any unnecessary red tape to make it easier to conduct clinical research in the province, promote the province as an ideal site for clinical research, and educate patients about the importance of clinical research with the goal of increasing trial recruitment.

The first step is currently underway. Clinical Trials Ontario is working to increase the speed and reduce the cost of multi-center clinical trials by streamlining the research ethics approval process to a single review in Ontario and harmonizing other administrative processes and platforms. This new approach will replace the current system in which each site must participate in an individual ethics review.

Clinical Trials Ontario is not the only way Ontario demonstrates its commitment to becoming a world-leading center for innovation and commercialization of research. MaRS Excellence in Clinical Innovation and Technology Evaluation (EXCITE) is another example of the province’s dedication in this area. EXCITE is a ground-breaking collaboration between a range of stakeholders in the health technology sector. It was created to harmonize health technology evaluation into a single, pre-market, evidence-based evaluation process for innovations with disruptive potential and specific relevance to health system priorities.¹ EXCITE evaluates medical technologies in the pre-market phase of development, and this contextual evidence can both align industrial technology innovation with health system demands and improve the quality and relevance of technologies still in development. It also helps streamline adoption by the health system―resulting in lower healthcare costs and increased patient benefits.²

The province has also created the Ontario Research Fund, which has committed $760 million to support cutting-edge research infrastructure, labs and equipment needed to conduct world-class research. Ontario also makes innovation affordable through its R&D tax incentive program, which is available to qualified businesses of any size and applies to a range of eligible costs that is broader than in the U.S. and many other countries.³

Additionally, Ontario’s life science cluster also benefits from the Health Technology Exchange (HTX). HTX manages a grant of up to $21.4 million on behalf of the Ontario government to finance emerging and established Ontario-based companies to develop, produce, and commercialize innovative, market-leading advanced health technologies.⁴ Since 2011, HTX has approved 38 projects for funding, investing $12.8 million into public/private commercialization projects worth $52.5 million.⁵

There is reason to believe that efforts like EXCITE and HTX are beginning to pay off.  In 2013, the Ontario Institute for Cancer Research, a body created to undertake cancer research and support commercialization and private sector partnerships, attracted a $1 million investment from Janssen Inc. for a prostate cancer initiative focused on multi-centered clinical trials.⁶ The initiative will leverage Ontario’s expertise in clinical trials, genomics, circulating tumor cells and molecular imaging.

Perhaps the most important lesson to be learned from the Ontario example is that the conditions necessary to attract clinical trials don’t “just happen.” Jurisdictions must be dedicated, collaborate with stakeholders and commit ongoing resources to ensure that they remain a preferred location to conduct research. It takes an ongoing process of policy innovation to make sure that research innovation is able to flourish.

 Michael Stewart, Senior Economic Officer, Ontario Ministry of Economic Development, Trade and Employment/Ministry of Research and Innovation (MEDTE/MRI) Email: [email protected]

1. http://www.investinontario.com/en/Pages/OS_lifesciences_programs_services.aspx

2.

http://www.marsdd.com/aboutmars/partners/excite/

3.

http://www.investinontario.com/en/Pages/news_details.aspx?NewsId=179

4.

http://www.htx.ca/about

5. Supporting Research and Development – August 22, 2013
6. HN - Ontario Institute for Cancer Research – Jan 10, 2014