Basket trials, along with umbrella trials and platform trials, are classified as master protocols which…
Doubly Nimble: why you should open global P1 clinical trials in Canada on Day 1
With agility increasingly becoming the most important global driver of success, it’s worth noting that Canadian oncology research center Phase 1 (P1) units are nimbler than ever. These units are typically more streamlined and are often led by one of the country’s top research oncologists. Match this with a niche oncology CRO partner with unparalleled expertise in the region, acting for global North American study sponsors in collaboration with these P1 units, and you have a doubly nimble advantage for your global oncology P1 clinical trial.
Canada Takes Top Spot
For the first time, Canada takes the top spot overall in the 2021 Best Countries Report₁, that states a nation’s perceived agility is the most important driver of strength in 2021, and the new Agility sub ranking carries most weight among the report’s 10 sub rankings. Of the 78 countries studied and ranked on the world stage Japan and Germany finish 2nd and 3rd respectively, while the United States is number 6 overall.
This year, the model that powers this report has evolved in response to a transformational year since the start of the COVID-19 pandemic. Cultural, economic, political and technological influences remain important, and two new categories have been added: social purpose and agility.
Canada ranks 1st in quality of life and social purpose, and Canada and the Nordic countries are viewed as the most committed to social justice.
Considered one of the best places to live in the world, with a high quality of life, stable business environment, educated workforce, and diverse population. Canada is also one of the most attractive places in the world to conduct global clinical studies. Yet only 6% of all ClinicalTrials.gov registered studies in Feb/22 are currently running here, clearly making it an untapped region of opportunity.
Despite the significantly fewer number of trials, world-class researchers and a diverse patient population help to make Canada one of the top 6 countries in the world for enrollment of clinical trial patients according to the FDA’s global clinical trial report. This is possible because Canada’s recruitment success rate in clinical trials is reported to be 98%, with sites in Canada that have as high as 22% of their total patient population participating in clinical trials.
That said, while the landscape in Canada is generally quite favorable to the success of global studies, unsurprisingly enrollment successes can vary from study-to-study.
Which is why it is vital for sponsors to be selective about who they partner with in order to most successfully recruit patients for their global studies in Canada. A niche CRO with local expertise that can leverage the disease treatment networks effectively is an obvious choice for connecting Canadian PIs to those studies most relevant for the patient population they serve.
What Sets Canada’s P1 Oncology Research Units Apart?
Nearly every aspect of society, including the way scientists conduct the testing of medicines has been affected by the COVID-19 pandemic. So too with Canadian oncology research center P1 units. The pandemic has led to process adjustments for these units allowing them to become more independent operationally, including dedicated legal for swifter contract review. Making these units even more streamlined and nimbler than they have been in the past.
By its very nature a First-in-human P1 trial must move quickly. Frequency and heightened safety monitoring combined with monthly compound reviews means that those working on trials in Canadian P1 units are accustomed to a fast pace. They pride themselves in being a nimble team working on fast paced trials, in contrast to other larger units within the same setting.
As mentioned above Canada’s nimble P1 oncology research units are led by an oncologist. Which means the PI for your P1 study also manages the unit. This contributes to streamlining the administrative steps required to move things forward for a trial. These same investigators are motivated and willing to enter into dialogue with sponsors about trial safety and other concerns. Their academic and research orientation means, if asked these PIs will offer their invaluable input on protocol and design as they are keenly interested in therapy breakthrough opportunities. The caveat of course, is ‘if asked’ which only a CRO with sound expertise and Canadian site network relationships is capable of undertaking effectively for your trial.
Canada First Offers Valuable Competitive Advantage
Monitoring the progress of clinical research is fundamental to obtaining successful outcomes because it ensures that constraints to success are identified, and then resolved in a timely and effective manner. This is particularly the case for the complex environment of oncology clinical research.
Close in geographic and demographic proximity to the U.S., Canada’s average annual number of cancer cases is projected to be 79% higher in 2028–2032 than it was in 2003–2007. While participation by Canadians in oncology clinical trials is 14% on average. Nearly triple the 5% participation rate in the U.S.
Canadian cancer patients are funneled through select oncology health centers across the country and will typically receive treatment at the same center throughout the evolution of their disease (1st, 2nd line, 3rd line, etc.). A factor that greatly aids in identification of possible oncology trial participants and in projecting enrollment rates.
The Canadian regulatory landscape is very advantageous for P1 trials – if done properly. Typically, large CROs will not adjust or customize modes of operation based on type of trial, size and/or structure of the sponsor, or even study phase. Given such an inflexible model, maximizing the opportunity that the uniquely nimble aspects of Canada’s P1 oncology research units provide does not fall under the purvey of the large global CRO.
On the other hand, Scimega, an experienced niche player, is always adapting processes to become ever nimbler, and makes a good match for the streamlined P1 units in Canada with; very efficient communication, long standing collaborative site relationships, and a team made up of former P1 oncology workers able to help streamline the steps to activating your trial.
Working with such a partner in Canada becomes a doubly nimble competitive advantage for your P1 oncology trial.
Proof by Performance
Too often, U.S. drug developers turn to Scimega upon realizing program timelines and targets aren’t being met, and then marvel at what Scimega can achieve for them in Canada. In fact, in doing so – or worse yet waiting until P2 – sponsors are losing the advantage Canada can provide when incorporated as a primary location in your drug development planning.
A Canada first approach provides competitive advantage in meeting early milestones for your global P1 oncology studies.
In keeping with the targets shared with its Sponsors, the Scimega team delivers consistent clinical trial start-up times 50% faster than the North American average, anoutstanding FPI track record, and trial sites often among top enrollers in global oncology studies.
When working with the right partner, early inclusion of Canada in the drug development process helps ensure things fall into place more effectively for your global oncology clinical trial because it is likely to result in earlier, significantly higher site engagement and performance.
More than ever Drug Developers want access to sites that can deliver on their promises of rapid FPI (first patient in study) and patient enrollment milestones. They need a CRO with established site relationships in Canada who can provide accurate study feasibility and viability assessments.
Operational efficiency and communication, clean, accurate data to meet deadlines and move projects forward quickly in a world where agility has become an important driver for success are key.
Sound yet adaptable processes to ensure a nimble response, with a high-quality standard and operation oversight of CRA activities and internal QA activities is critical. And of course, steady and high enrollments rates thanks to the selection of the right sites for your study design, along with a keen ability to engage oncologists and site teams at the highest level. Especially under the current pandemic circumstances.
The Right Partner for Your P1 Trial in Canada
Acting for small to medium size global North American study sponsors in collaboration with Canada’s oncology research centers Scimega is a niche oncology CRO. Our optimal operations design is robust in the face of transition and allows us to go above-and-beyond for your study.
We’ll work with you to devise innovative solutions specific to the unique challenges of your oncology clinical trial. Explore an expansion with us. Scimega has a proven track record of successful study conduct in Canada bundled with 25 years of lessons learned!
Contributed by: Julie Martin, CEO & co-Owner
References: The 2021 Best Countries Report, is a ranking and analysis project by U.S. News & World Report; BAV Group, a unit of global marketing communications company VMLY&R; and the Wharton School of the University of Pennsylvania.