The need to transform traditional clinical trial process to a leaner and more cost-effective model…
US Sponsors of oncology clinical trials often consider expanding their programs to Europe and Asia rather than to the nearby Canada. A decision sometimes made based on old stories and inexact perceptions of the Canadian landscape, and at the expense of study timelines and increased sponsor costs.
Debunking old stories about conducting oncology trials in Canada
Concerns about the difficulty of Health Canada submissions or the Canadian Healthcare system flout the reality that with proper guidance, “nearshoring” to Canada is an optimum solution for US-based biotechs and mid-size biopharmas looking to quickly expand their programs.
The oncology clinical trial landscape in Canada has tremendous potential with 2.1x fewer Phase III studies, and an astonishing nearly 8x fewer early phase studies ongoing. Clearly making Canada an untapped resource located right next door to US Sponsors.
Investigators: The Canadian research landscape is populated by top tier oncologist researchers. Passionate about great science and expanding the available treatment options for their patients, especially in advanced, recurrent, and metastatic cases.
Trial competition at site: Selecting sites that are optimally set-up for a specific study design is critical to enrollment success. Available oncology trial opportunities are 2:1 and 8:1 fewer at Canadian sites than in the USA. While Sponsors coming to Canada may only consider the well-known 3 larger Canadian centers, it is possible to collaborate with over 40 Canadian oncology research centers with sufficient capacity and resources.
Local regulatory requirements: Navigating the Canadian institutional and provincial ethics approval processes may seem complex at first glance however these processes can bring great benefits to a program (ex: starting multiple sites under the same unique application). With the right CRO partner US Sponsors can exploit these processes to their advantage, selecting lead sites and a start-up strategy that are best suited for their specific program.
Canada’s Healthcare System: Due to the structure of Canada’s healthcare system and public drug reimbursement plans, most Canadian patients elect to be followed by the same Canadian center throughout the evolution of their disease. This phenomenon helps yield more precise feasibility data and more accurate enrollment projections. Investigators become very knowledgeable about their patients.
In addition, unlike in the US no competition exists among Canadian centers for patients. In fact, Canadian investigators and sites refer patients to other investigators and sites with open studies that meet the needs of the patient. Also, participation rates in sub-studies in Canada is particularly high, a key advantage when most oncology studies contain multiple biomarker studies and optional tissue banking.
Health Canada: The Canadian regulatory equivalent to the FDA and the gate keeper of clinical trials, many Sponsors believe that applying for the study Clinical Trials Application (CTA) in Canada is lengthy and onerous.
In fact, experience proves the CTA can be completed in 7 days. With the Investigator Brochure and the FDA IND application module 3, the submission process is extremely efficient, and at a fraction of the cost of an IND. The Health Canada CTA approval process is a default 30-day deadline for a response to be received. For additional cost and time savings multiple studies under the same drug program can be submitted together, and without penalty Sponsors can opt to withdraw their CTA at any moment during the process.
Drug labels: Though templates of drug labels that will be used for a study must comply with Health Canada’s requirements, these need not be included in the CTA. Labels for study drugs to be presented to patients must bear both English and French languages, in an abridged version. It is sometimes a challenge to have all necessary information listed on the study drug label (ex: small vials).
An experienced Canadian oncology CRO designs drug labels for Sponsors that comply with Health Canada’s requirements while preserving the Sponsors’ original template.
Translation of study documents: Some Canadian centers see patients who speak languages other than English. A vast majority of Canadian centers will accept to work from an English Informed Consent Form for the initial submission to their local ethics board, and final approved templates may be translated once final ethics approval is obtained, thus simplifying the process. In addition, any documentation to be presented to patients (ex: patient diary, quality of life questionnaires, etc.), must also be translated into the patients’ spoken language (as required) and approved by the local ethics boards.
Health Canada does not require receipt of a translated Master Informed Consent as part of the CTA. An effective Canadian oncology CRO should readily and promptly be capable of Canadianizing any US Master Informed Consent Form in order to comply with Canadian laws and application requirements, prior to the CTA submission to Health Canada.
Start-up times: Too often we hear from other parties that a Canadian site took 72 weeks to open. Or that only 2-3 Canadian sites could be identified for program participation. These are unfortunate urban myths spawned by a limited local knowledge and inexistent or poor site relationships. Selecting the right start-up strategy and lead sites for a given program is critical to avoiding such disappointing results.
How do you achieve the fastest site start-ups? Information and knowledge of the sites is key. For US Sponsors, this can be achieved by selecting the right study partner for Canada. US Sponsors unsure about their Canadian opportunity should reach out to Scimega and ask for a Reverse Feasibility assessment.
In a few days, with a confidentiality agreement in place, we produce program-specific preliminary data on site and enrollment potential, as well as a competition analysis for Canada. US Sponsors can therefore be well equipped to make an informed decision about their Canadian opportunity.
We also encourage you to consult our explanatory package on the Canadian regulatory scene, that includes detailed responses to questions about Canada we frequently receives from US Sponsors.
How can US Sponsors harness this potential?
As for any region, in Canada the identification of highly motivated sites, that have the required patient population, with the resource capacity to conduct your oncology clinical trial, is key to success in the region.
We are eager to help bring cutting-edge oncology therapies to Canadian patients, and share our Canadian know-how with US Sponsors.
A flexible niche player with a unique business model (oncology-focus, Canada only), Scimega frequently collaborates with a wide range of North American and global oncology study vendors. Our internal processes and collaborative approach are designed to optimally mesh with these often-larger teams.
The result of our experience and local knowledge means Scimega-managed sites are 50% faster to start-up, a significant contribution to Sponsors saving them both time and money. Canadian sites are familiar with our clinical trial agreement (CTA) template. In the past year alone Scimega has successfully negotiated 73 CTAs and a further 74 site confidentiality agreements.
Established relationships with site personnel at many levels (investigators, coordinators, legal teams, other functional departments), and our CRAs, who for the most part come from the sites, further enhance our ability to leverage site relationships for Sponsor benefit. Our team is comprised of fully trained oncology specialists who professionally manage the selected Canadian sites. With a high volume of Canadian studies managed Scimega CRAs are in routine contact with Canadian site staff, allowing our Sponsors’ studies to be kept top-of-mind for recruitment staff. Knowing the motivation and the research passions of Canadian Investigators, is a priceless asset.
Scimega knows the Canadian oncology landscape with 20 years of unparalleled oncology experience in this country. With twenty years of only oncology, focused only in Canada we have managed nearly 100 studies with 70% in the phase I-II setting, across the full spectrum of malignancies. None of which have ever been rescued by another CRO!
Contributed by: Patrick Smith, M.Sc., Clinical Trial Leader