Eight Reasons to Choose Canada for Your Phase 1 Clinical Trial

For many study sponsors, the end goal of their clinical drug development program is to enter the United States drug market. However, conducting your Phase 1 clinical trial in Canada is an alternative route that can fast-track the CTA process and get the approval for the initiation of your study. It also allows you to use your limited interactions with the United States Food and Drug Administration (FDA) efficiently to discuss matters that truly add value to your asset after you have collected the results of your clinical trials conducted in Canada.

Several of the reasons to choose Canada for your Phase 1 clinical trial and CTA process  include:

1. To initiate your study faster and to shift IND interactions with the FDA until after you have gathered early-phase clinical research data – Typically, you can have only a few meetings with the FDA regarding an IND application, including a pre-IND meeting and meetings at the end of the Phase 2 and Phase 3 studies. For a first-in-human study, the pre-IND meeting discussion will focus on the safety of a drug candidate in humans, including its starting dose, the aggressiveness of its dose escalation, safety concerns, and monitoring. Performing your first-in-human studies in Canada enables you to put off interactions with the FDA until a later date when you have collected more complete data. This approach shifts the conversation in the initial meeting with the FDA from the requirements for a safe first-in-human study to the expectations for Phase 2 study protocols. Submitting a clinical trial application (CTA) to Health Canada is an alternative route, which allows you to initiate your first-in-human studies faster. The CTA process includes a review by Health Canada within a fixed 30 calendar days. Once a Clinical Trial Application (CTA) is approved, you can start to collect clinical data promptly. Health Canada does not extend their 30-day review period while they request clarifications unless you are not able to satisfy Health Canada with your responses in these 30 days. Submitting your study in Canada allows you a low-risk regulatory strategy while getting good feedback from the Canadian regulator on running your study safely and in line with regulatory acceptance. At BioPharma Services, we have seen indications of declining first-in-human studies in the United States due to this Canadian advantage.
2. To avoid the risk of your study being put on a clinical hold – When submitting an IND application, there is a risk of the FDA putting the study on a clinical hold due to concerns related to the compound itself or manufacturing. A clinical hold can be very damaging to a company by negatively impacting its ability to attract investors and by causing delays. In contrast, Health Canada does not have the equivalent of a “clinical hold.” Instead, if questions arise, Health Canada will contact sponsors/clinical research organizations (CROs) and request additional information; sponsors must respond to such requests within 48 hours. If Health Canada’s review determines that a Clinical Trial Application (CTA) is not going to be approvable, the agency contacts the sponsor/CRO and advises them to withdraw the CTA without prejudice. This allows you to withdraw and resubmit the CTA when you have acquired the necessary additional information without receiving a clinical hold or rejection. Moreover, there is no need to report the withdrawal to other agencies, reducing the risks a company faces.
3. To reduce the amount of preclinical and manufacturing data needed for study approval – In the United States, you must submit a full set of pre-clinical packages with your IND application, including the finalized reports of the results of animal studies, toxicity data, and, if applicable, any prior human research, in addition to manufacturing information, clinical protocols, and investigator information. In contrast, an initial CTA process submission to Health Canada does not require the finalized pre-clinical reports. However, it requires a summary of the pre-clinical studies indicated in the Investigator’s Brochure, supplemented with up-to-date safety and clinical data. Moreover, CTA contains quality information regarding the chemistry and manufacturing data of the drug used in the proposed study. A Clinical Trial Application  does not require additional supporting quality information for first-in-human studies. These are some of the advantages of running a clinical trial in Canada, to save time in getting the study submitted and approved.
4. To benefit from a straightforward regulatory process compatible with FDA requirements – If you have not previously worked with Health Canada you may have concerns about the alignment of its regulatory requirements with those of the FDA. However, the FDA considers Canadian studies to be fully comparable to studies conducted in the United States, and the findings of Canadian trials can be readily used for FDA applications, as Canada is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the clinical trials in Canada are conducted under ICH Good Clinical Practice (GCP). Moreover, data collected for an IND application can be reformatted for a CTA submission to Health Canada. An experienced CRO like BioPharma Services, which has repeatedly and successfully been audited by both the FDA and Health Canada and has the expertise to perform studies for the FDA, can assist you in this process.
5. As Health Canada has clear guidelines for filing CTA amendments – The circumstances, under which changes in the study protocol necessitate submitting an amendment, have been defined extensively by Health Canada. Two types of amendments can be filed in the CTA process – Clinical and Quality Amendments. Clinical Amendments include modifications to an authorized protocol that affect the risk to study volunteers, whereas Quality Amendments encompass changes to drug supplies for clinical trials. CTA amendments are submitted for approved CTAs. If a Clinical Trial Application  under active review requires an amendment, the reviewed CTA should be withdrawn, and the amendment should be submitted as a new CTA.
6. To profit from financial incentives – Canada has established the Scientific Research and Experimental Development (SR&ED) tax incentives to promote research and development activities in Canada. In addition, conducting a first-in-human study in Canada may be associated with savings of certain IND-associated fees.
7. As Health Canada has experience with various drug candidates and disease areas – Health Canada has reviewed and approved CTAs for many indications and different types of drugs, including not only small molecules but also siRNA oligonucleotides.
8. As Canadian sites are easily accessible for North American clients – When study sponsors consider an alternative location for their clinical drug development program, Australia often comes to mind, as it also offers a reduced submission burden and financial incentives. However, conducting a study in Australia can be challenging due to differences in the time zone, which hinder collaboration. In addition, shipping samples to Australia and traveling there for study monitoring can be expensive and time-consuming for North American sponsors. These challenges do not exist when a trial is conducted in Canada.

An experienced Canadian CRO can be a valuable resource for sponsors who plan to conduct a clinical trial in Canada. BioPharma Services is a full-service CRO with niche expertise in Phase 1 clinical trials, including first-in-human and bioequivalence studies, that is proficient in navigating the CTA process. We have experience working with both Health Canada and the FDA and have access to diverse volunteer populations. Moreover, a number of large pharmaceutical companies have already completed their first-in-human studies in Canada in collaboration with us.

Our multidisciplinary team can help you fast-track your clinical drug development program and shift your interactions with the FDA until after you have gathered early-phase clinical research data.

If you want to advance your drug development program by collaborating with a service-oriented clinical partner with a proven track record, complete the form below to schedule a discovery call with a member of BioPharma’s scientific and medical team.