Several years ago the Ontario government began noticing a trend: major clinical trials were being conducted here less frequently. Pharmaceutical companies, it turned out, were increasingly choosing to run trials in developing nations, where costs are lower.
Clinical Trials Ontario is a new organization that hopes to combat that trend and attract major clinical trials back to Ontario. The nonprofit, which is right now fully funded by the Ontario Ministry of Economic Development and Innovation, wants to make us more competitive again, by making the most of our key advantage: the quality of our research and clinical practices.
"We are not going to compete with emerging economies on an absolute cost levels," says CTO executive director Ronald Heslegrave, "but we do have the support clinically… Quality is as important or more important than cost itself. If you fail on the quality side, the regulators will never approve your product anyways."
CTO's first step will be to streamline the regulatory hurdles that can make it onerous for pharmaceutical companies who need to conduct large-scale trials. Currently, if you want to run a trial with a large population distributed across multiple sites, for instance, you need to get separate sign-off for your trial procedures according to the approval process of each of those sites. Twenty sites? Twenty approval processes. This, says Heslegrave, is unnecessary. "We can devise a centralized approval process which maintains the highest standards in trial protocols, but make the process more efficient and easier to navigate." (Ontario instituted a centralized review system for cancer trials several years ago; CTO hopes to expand that centralized approach to cover other disease areas.)
If Ontario does see an increase in clinical trials, Heslegrave says, there are two key benefits that follow. One is that "we need clinical trials for the health of Ontarians—this provides access to investigational drugs prior to them being approved on the market." The other is a job creation spin-off. "If the trials are conducted here... they are more likely to be analyzed here as well." In other words, our biomedical research sector would grow to provide support for the trials.
CTO's board includes pharmaceutical industry representatives as well as academics and business experts. Collectively, they hope, they can make the case that cost shouldn't be the determining factor in where clinical trials are conducted.
Writer: Hamutal Dotan
Source: Ronald Heslegrave, Executive Director, Clinical Trials Ontario