Pursuit of a path from discovery to drug approval as quickly as possible is a…
At every industry event, from ASCO to DIA to ASH, I meet with senior executives from oncology drug developers looking to mitigate recruitment risks for their ongoing or upcoming trials and are considering Canada as a solution. This posts contains all important Frequently Asked Questions concerning Oncology Clinical Research In Canada.
Q1. Do I need to have a Canadian office in order to submit my Clinical Trial Applications (CTA) to Health Canada or Can Scimega act as our regulatory Signing Officer?
A1: A sponsor, inside or outside of Canada, can submit their CTA by itself. 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 application are complete and accurate and to provide any additional information or samples required to assess the application. Scimega can serve as your Canadian representative for all your trials.
Q2. Do Canadian sites recruit as many patients as U.S. sites? How many sites would I need from Canada?
A2: 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 fewer sites (1/3 less) are needed to conduct your trial in Canada. So, if you are looking to initiate 30 sites in the U.S., we would only need to secure the participation of 10 sites in Canada to recruit 50% of your subjects. 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.
Q3. Should all my study documents (Protocol, IB, ICF, etc.) be translated into French for sites in Canada?
A3: You only need to provide an English and French version of the written study information destined to study subjects (i.e. ICF, patient diary, advertising) for sites in Quebec. A bilingual Drug Label is required for your Health Canada Clinical Trial Application. Refer to the following link for Guidance on Labeling of Pharmaceutical Drugs for Human Use in Canada.
P.S.: Re-labelling of study medication can be done on site.
Q4. We’ve never dealt with Health Canada and have heard that the documents and procedures differ from those of an IND in the U.S.. What is required to file a Clinical Trial Application (CTA) with Health Canada?
A4: The Canadian CTA is actually very similar to the U.S. IND with only a few differences. For Instance, contrary to the US IND which is an open submission throughout the product development and for which new protocols are submitted as amendments, the Canadian CTA requires a new CTA submission for each protocol. The amendments (CTA-As) are submitted for modification of the clinical or the quality information, per protocol.
Download this Fact Sheet comparing the Canadian CTA to the U.S. IND Submission Process.
Q5. Are there any exceptions to the Health Canada One (1) Protocol One (1) CTA policy?
A5: As a matter of fact, when a company has two different protocols, looking at the same molecule, and set to start at approximately the same time, then you are eligible to submit both protocols under a single application. This start-up strategy is a cost-effective solution often used by oncology drug developers willing to commit to expanding one of their two trials immediately into Canada and wanting to get pre-approval for the second trial to expedite start-up should they encounter recruitment hurdles in the U.S.