Successfully designing and conducting oncology trials is not getting easier. Challenges that prevent us from reaching our objectives are on the rise with the evolution of oncology trials. The compounded causes for a trial requiring ‘rescue’ often involves a mix of trial competition over the targeted patient population, technology, process, and study design. In addition, unsatisfactory sponsor/CRO/site relationships may also be central to the need for a rescue strategy.
Unless there is a safety or regulatory compliance issue significant enough to terminate a study, sponsors rarely opt to abandon a trial that is not going well. It becomes a matter of doing whatever it takes to get the study back on track. Geographic expansion as a rescue strategy can be critical to the survival and success of an oncology program at risk of failure.
Where to Select the Right Region and Study Partner
Once the need to expand an oncology trial is identified, selecting the right region is critical. Key determining considerations include the availability of the targeted patient population, if the local standards of care is aligned with the study design, as well as the ability to open sites in the new region fast. Indeed, when expanding geographically, especially in a trial rescue context, speed is of the essence.
In order to fully leverage a geographic expansion strategy, the selection of the right study partner is critical. A specialized regional CRO well positioned to optimally exploit the new region’s potential to ensure overall trial recovery and success, and to do so within aggressive study timelines is an important partner to seek out.
Canada as a Region of Choice for Oncology Trial Expansion
Compelling facts about the local clinical investigative landscape positions Canada as a region of choice to turn to when your oncology trial requires a swift and effective ‘rescue’ plan due to an enrollment shortfall, or delays in reaching other important study milestones.
Of all industry-sponsored oncology trials running in North America, less than 20 percent expand to Canada. Considering five key cancer immunotherapies in early clinical development today, these compounds are almost six times less likely to be available in a trial within Canada versus the U.S. Exciting and cutting-edge oncology clinical research is taking place, but much is excluded from Canada.
The outcome is that Canadians are eager to participate in oncology clinical trials, while very few have the opportunity to do so. This also means potential Canadian study participants make up a largely novel therapy naïve population in comparison to their U.S. counterparts. The lower level of trial competition at Canadian sites will also invariably play out to your oncology trial’s advantage. Canadian patients can significantly contribute to certain cohorts for which enrollment is less than anticipated at U.S. sites, thereby also reducing recruitment delays and associated costs. Therefore, choosing to expand your trial to Canada as part of your rescue plan can turn your trial’s chances of success around.
Involving a regionally specialized CRO with a proven track record of accountability for their actions and outcomes will ensure you fully exploit Canada’s best clinical research attributes.
- The nature and structure of the Canadian health care system results in patients being followed at the same center throughout the evolution of their disease. This represents a competitive advantage in regard to ease of access to historic data to precisely project study enrollment performance
- Pre-screening efforts are further facilitated by accessing specific sources of patients (example: follow-up on patients having received a 1st line therapy and ‘catch’ then when they progress)
- In Canada oncology patients are cared for within a network of cutting-edge comprehensive cancer centers across the country which possess the necessary facilities, resources, and experience to conduct not only late phase oncology trials, but early phase trials as well, including dose-escalations
- Because of the public healthcare system, Canadian oncologists do not compete for patient care, and both physicians and oncologists from nearby centers will happily refer patients to a neighboring care center running a trial
- Oncologists have established referral systems, both within their own sites as well as from multiple other institutions across Canada
- Tapping into these referral systems increases access to specific disease indications – optimizing enrolment for orphan/micro populations
- When using the right study partner, the preparation of the clinical trial application for submission to Health Canada can be done under 10 days based on the IND Module 3. Health Canada’s approval process follows a 30-day default period
As for speed, the following Seven Tips for efficient study start-up in Canada are useful considerations when expanding your rescue strategy to this region:
1) Involve Canadian oncologists early on and gather country-specific insight regarding possible enrollment barriers, competing therapies, and study design
2) Exploit provincial and central ethics approval pathways
3) Carefully and strategically select which site will act as lead applicant for ethics approval
4) Identify language requirements for study documents
5) Know ethics boards policies and specific requirements (ex: consent forms, study application, etc.)
6) Conduct key start-up activities in parallel when possible, in order to avoid delays
7) Proactively engage site teams in order to expedite study drug release and site activation
When sponsors turn to Canada in search of a swift and effective regional ‘rescue’ strategy there are many questions to be answered. Reaching out to a Canadian partner with 20 years of business operations dedicated to oncology and whose answers are substantiated by long-standing performance metrics provides sponsors with the confidence they need to make a sound strategic decision.
Contributed by Scimega Research: Julie Martin, Director, Clinical Operations