Canada To Significantly Alter Clinical Trials Landscape

This week, the Canadian Healthcare Association announced the establishment of the Canadian Clinical Trials Coordinating Center. This center is a collaborative effort created by the Canadian Institutes of Health Research, Canada’s Research-Based Pharmaceutical Companies (Rx&D), and the merged organizations of the Association of Canadian Healthcare Organizations and the Canadian Healthcare Association.

As more drug companies begin moving their clinical trials to emerging markets to save costs and encounter less stringent regulations, Canada wants to remain competitive and draw in its fair share of drug developers . The newly created Canadian Clinical Trial Coordinating Centre is the government’s attempt to recreate the country’s clinical trial landscape, in turn drawing more foreign drug developers into the country. This centre aims to ease and quicken the regulatory process for clinical trial approval. It has released a report of its plans, which was drafted in 2012 and is entitled “Action Plan to Help Attract More Clinical Trials to Canada.” This plan is expected to “improve the coordination of clinical trial activities and streamline regulatory processes for companies and researchers.” The current process for a clinical trial approval includes various forms, contracts, and standards, which must be completed across different jurisdictions. Different jurisdictions and academic sites can have different standards and protocols, which all make a quick, uniform approval difficult to attain.

Russell Williams, the president of Canada’s Research-based Pharmaceutical Companies, also known as Rx&D, says that the country is seeing a decrease in the number of clinical trial applications because of the “cost, quality, and time required” to conduct clinical trials. The reduction in the number of clinical trials in Canada has a negative effect, not only on Canada’s economics, says Williams, but also on the country’s “human and social” order.

In the 2012 action plan, the Canadian government has come out in support of simplifying ethics reviews, creating a national database of patient registries, and allowing brand name drugs to carry longer standing patents. The Canadian government and Rx&D will be providing $750,000 each to start the Canadian Clinical Trial Coordinating Centre’s funding. The organization will get $1.545 million in funding over the next 3 years.

However, some industry experts are skeptical about the effect of this new model. Amir Attaran, the Canada Research Chair in Law, is skeptical about the plan’s ability to keep drug companies from having too much influence over the process. “Obviously, one wants that industry not exert control or censorship over study design and publication of results,” said Attaran. Other industry experts have expressed concerns about the model’s lack of focus on clinical trial transparency, which has been a longstanding concern in Canada, the CMAJ says.