By Daniela Fisher
All photos courtesy of Clinical Trials Ontario
Across Canada
Clinical Trials Ontario: cultivating Ontario’s clinical trials landscape
G
etting a multi-site clinical trial approved in Ontario can be a time-consuming and headacheinducing task. Currently, multisite clinical trials need to be approved at every site participating in the clinical trial, which may be between five to 20 sites in Ontario alone. Moreover, the reviews from independent institutional ethics committees may have different requirements for approval that can be inconsistent with one another. An inefficient approval process is in part the reason why Ontario is experiencing a drop in the number of global pharmaceutical companies basing their trials in Ontario. In a move to stop the clinical trial dispersion, a new non-profit organization Clinical Trials Ontario (CTO) has been established to make Ontario a more attractive jurisdiction for drug development, by reshaping the province’s clinical trials infrastructure landscape. With an end goal of making Ontario more competitive globally, CTO aims to streamline the ethics review process and the con-
tract approval for industry-driven multi-site trials, without compromising the province’s ethical standards. CTO also intends to work with industry, research and government partners to gain access to global clinical trial leadership, as well as launching an initiative to explain the potential advantages of clinical trials to the public, as well as patients and their families. “The idea behind Clinical Trials Ontario is to modernize and reform the clinical trials infrastructure associated with getting initial approval to conduct a clinical trial, and maintaining ongoing ethics approval while ensuring the highest standards of research ethics” says CTO’s Interim Executive Director, Dr. Ron Heslegrave. “We’re fundamentally changing the process.” The redesign is much-welcomed by researchers and companies alike. It is also much-needed, as Ontario has experienced a 10 to 12 per cent annual loss of global clinical trial activity in recent years. As pharmaceutical companies veer towards countries that offer larger tax breaks for clinical trials, or maintain quality at
cheaper costs in developing nations, Ontario is losing its appeal as a drug development location. To combat this, CTO was launched at the 2012 BIO International Convention, through the Ministry of Economic Development and Innovation (MEDI). The not-for-profit is a part of Ontario’s Life Sciences Commercialization Strategy. As an independent corporation, CTO is currently receiving funds from the Ontario provincial government, with hopes to eventually be financially selfsustaining. Although the organization was recently launched in June 2012, CTO has been in the works for a number of years. From 2008 to 2009, the Ministry of Research and Innovation and the Ministry of Economic Development and Trade, which became MEDI in 2011, set up two task forces to look at the clinical trials crisis. For Dr. Heslegrave, who was on the second of the two task forces, the main issue was improving Ontario’s competitiveness through superior efficiencies in infrastructure without reducing the safety for patients. SEPTEMBER 2012 BIOTECHNOLOGY FOCUS 21
