The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Canada remains a prime destination for the expansion of both early and late phase oncology clinical trials due the fact that most Canadian cancer patients are treated in publicly funded teaching institutions located in large metropolitan areas. This centralized approach facilitates rapid site selection and enhances patient enrollment, especially when your compound satisfies an unmet need that give investigators an opportunity to offer more clinical trial options for their patients.
Despite these advantages, sponsors may still shy away from Canada simply because they lack strategic relationships with investigative sites or are unfamiliar with the drug availability and reimbursement landscape.
To gain a better understanding of Canada’s dynamic and sometimes complex regulatory environment you can read the full article on this topic, published in the April/May issue of Applied Clinical Trials magazine.
The rise of targeted therapeutics has probably forced you to start thinking about regional expansion much earlier than was previously required. Once you’ve decided to expand beyond the United States, however, you need to evaluate whether the possibility of having to cover the comparator arm costs outweighs the risk of not being able to open enough sites or recruit enough patients. Here’s what the VP of Clinical Operations at one U.S. biotech had to say about his experience in Canada.
“Having had recent Phase II experience where combination drugs were provided to the Canadian sites, we found that Canadian investigators were highly engaged in our studies and that their participation helped to significantly improve our enrollment times. Therefore, a sponsor must carefully weigh the cost of supplying comparator drugs, which can be significant, against the potential cost of time-to-market delay due to prolonged enrollment.”[Tweet “Participation of Canadian investigators helped to significantly improve enrollment times”]
It’s clear that opportunities for reimbursement do exist in Canada, but it’s important to note that even if your comparator arm drug is not on the provincial formularies for your line of therapy, and therefore not covered, there are other factors to consider such as patient enrollment potential, and investigators’ scientific interest. These are key to a trial’s success and will often outweigh any costs if it means meeting your timeline objectives.
To ensure success of your oncology program in Canada you really do need high quality, timely data collection and a pro-active approach to clinical trial management. Watch this short video to see how other U.S. oncology sponsors have neutralized drug reimbursement costs through the Reverse Feasibility Program. You can also sign up to receive quarterly updates on which types of studies our Canadian investigators are looking to participate in.
Our mission is to attract cutting-edge oncology trials to Canada and we are uniquely qualified to oversee your oncology clinical research in this country. This means helping you evaluate your trial’s potential in Canada and then meeting your timelines by accelerating start up and bolstering enrollment.
Please share your clinical trial expansion experiences and let us know what you think.