Navigating Canadian Regulations for Oncology Clinical Research – Part I

Navigating Canadian Regulations for Oncology Clinical Research 
Your Questions Answered Part I

Senior executives from oncology drug developers looking to mitigate recruitment risks for their ongoing or upcoming trials and are considering Canada as a solution are looking for answers to their questions.

This post is Part I of a two-part series summarizing 5 answers that respond to 10 frequently asked questions by U.S. drug developers about oncology clinical research in Canada.

1) How long does it take to produce the Health Canada Clinical Trial Application (CTA), and is it difficult?
An effective regulatory group experienced with submissions to Health Canada can complete a CTA in 7 days if the FDA IND application module 3 is already available. The Health Canada CTA approval process is a default 30-day deadline for a response to be received.

2) Does the sponsor need to have a Canadian office in order to submit Clinical Trial Applications (CTA) to Health Canada or is there another option?
Sponsors, inside or outside of Canada, are eligible to submit their own CTAs. However, when the Sponsor is located outside of Canada, a Canadian Scientific Officer or Representative must sign the administrative form HC-SC 3011 and certify that the information and material contained in, or referenced by the applicant are complete and accurate, in conjunction with any additional information or samples required to assess the application. For example, Scimega can serve as your Canadian representative for your trial.

3) Are there any exceptions to the Health Canada One (1) Protocol One (1) CTA policy?
When a Sponsor has two different protocols, looking at the same molecule, that are set to start at approximately the same time, it is possible to submit both protocols to Health Canada under a single Clinical Trial Application (CTA). This start-up strategy is a cost-effective solution often used by oncology drug developers willing to commit to expanding one of two trials immediately into Canada with a submission for pre-approval for the second trial to expedite start-up should recruitment hurdles in the U.S. arise for the second trial.

4) How can the standard of care be determined for each province?
Health Canada’s website lists oncology treatments that have been approved for standard of care in Canada. In addition, various provincial websites exist describing which oncology treatments are reimbursed by the local public health care program.

Note that each of the 12 Canadian provinces have a distinct public healthcare program and it is possible that a treatment may be reimbursed by one provincial program, but not by another. Although this information is publicly available, a second important step remains to validate how reimbursed treatments are used at the site-level, in a real-life standard of care context. This validation can be done through discussion with key oncologists. Access to a network of key oncologists is an important contributing factor to achieving an accelerated study feasibility process.

5) What can be expected from Canadian sites in terms of enrollment?
Canadian Investigative Sites capable of conducting early and late oncology trials include Major Cancer Centers as well as Regional Cancer Centers, and some private clinics (ex: prostate cancer), spread throughout the 12 provinces (scroll down to the middle of the page for an interactive map providing a visual overview of Canadian Sites with this link). Selecting the right Sites for a trial is critical, and to do so one must consider many factors such as the targeted patient population, the proposed study treatment and how it fits within the local standard of care practices, the level of trial competition at the Sites being considered, the experience and interest of the Site staff towards the study, the level of complexity of the trial (ex: early versus late phase), and the required study procedures (ex: 12hrs PK sampling, multiple days in-patient admission, study drug storage requirements, etc.).

Depending on competing trials and drug access, Canadian Sites will typically out-recruit U.S. sites by a margin of 3-to-1. This has a significant and direct impact on the clinical operations budget since 1/3 fewer sites are needed to conduct your trial in Canada.

So, if you are looking to initiate 30 sites in the U.S., it would be necessary to secure the participation of 10 sites in Canada to recruit 50% of the subjects for a study. This is due primarily to Canada’s centralized public healthcare system that involves federally funded Cancer Networks and established centers of excellence in each province with extensive clinical research infrastructure, including internationally renowned researchers.

Contributed by: Julie Martin, Director, Clinical Operations