With the emergence of basket trials in the early-phase oncology setting, clinical research teams are…
Participant diversity in clinical trials can be quite challenging to achieve. With COVID the concern about appropriate demographic representation is now even more in the spotlight when drug developers attempt to evaluate the safety and effectiveness of new compounds.
Innovation in biopharma is so much more than bringing new therapies to market. It involves new ways of thinking, and better ways of doing business. Since the mid-2000s BIO (Biotechnology Innovation Organization) has led the charge on the clinical trial participant diversity front with its Right Mix Matters campaign, and other related initiatives.
The events of 2020 have brought concerns about diversity and inclusion in clinical trials much more sharply into focus. More than ever, cutting-edge biotechs are increasingly concerned about ensuring their clinical trials adequately address getting the right mix of participants into their clinical trials.
What Does U.S. Data Reveal?
Black or African Americans in the U.S. represent 13.4% of the population, according to the U.S. Census Bureau. No more than 5% of these populations are clinical trial participants, as reported by the FDA. Similarly, Hispanic or people of Latin descent represent only 1% of clinical trial participants in the U.S.
In Australia only 2-3% of adult cancer patients participate in clinical trials overall, and the rate is even lower among minority groups and women. This according to the Cancer Council (2017).
Recent data from the CDC and Mayo Clinic reveals that racial and ethnic minorities are disproportionately affected by COVID-19 in the U.S. While past CDC research shows that our health is in part determined by factors such as income, where we live, and education. No doubt our access to affordable health care is another important contributing factor.
A large number of people of color in the U.S. have no — or reduced — access to healthcare. As a result, they lack the opportunity to learn about clinical trials and how they can benefit by participating. Clinical trials often take place at the most advanced U.S. research institutions, where doctor-patient conversations for people of color do not frequently take place. In addition, limited resources mean potential participants of color are unaware of how to find clinical trials, or approach advocacy groups for assistance.
How Does Canada Differ?
Canada boasts the highest percentage of foreign-born citizens among all G8 countries. A diverse population combined with a universal healthcare system for all Canadian citizens offers a compelling opportunity for cutting-edge U.S. biotechs striving to ensure global trials get the right mix of participants.
Unlike Australia, where people of color make up only 9.3% of the population (including: Aboriginal Australians, Blacks, people from the Pacific Islands, Asia, and India) Canada’s demographics are more reflective of that of the U.S. In 2016 immigrants in Canada represented 26% of the total Canadian population, the highest proportion among G8 countries. Projections to 2036 indicate people of color will make up about one third (31% to 36%) of the total Canadian population.
The advantage of universal health care in Canada means all citizens receive coverage for basic health care services, and no legal resident is denied care. Access for Canadian citizens is granted regardless of status, income, employment, health, or age. The administration of Canadian heath care is on a province by province basis, and the entire health care system is paid for by taxes.
Oncology Trial Launch Options Beyond Diversity – Think Canada First!
Besides its diverse demographics and universal health care system as a compelling opportunity for cutting-edge U.S. oncology biotechs seeking more diversity among participants for their global trials; Canada is close in geographic 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%. Nearly triple the 5% participation rate in the U.S.
In addition, 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 within the diverse Canadian demographic make-up.
Although it is probably too soon to fully appreciate the impact of the COVID-19 outbreak on our industry, Canada has had the good fortune of seeing less disease. As this trend continues, the region is in an excellent position to contribute to oncology trial patient enrollment in both the short and the long term. In addition, some Canadian sites that were early adopters of “new normal” strategies continue to implement them, remain ahead of the curve, and are emerging as high performers over the long haul.
Choose the Right Expertise for the Region
Mobilizing an expert Canadian team significantly enhances study start-up and overall performance. 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, with trial sites often among top enrollers in global oncology studies.
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 that can provide swift, accurate study feasibility and viability assessments.
Scimega is a Canadian niche oncology CRO that serves small to medium size biotech companies in clinical development of cutting-edge oncology therapies in Canada. We consistently deliver our services with a strategic focus on Sponsor program success, and our team’s ability to engage oncologists and site teams at the highest level is unparalleled. Even under the current pandemic circumstances.
Processes that ensure high-quality, and operation oversight of CRA activities and internal QA activities is the gold standard with Scimega. And of course, steady and high enrollments rates thanks to the selection of the right sites for your study design.
With inspection ready processes and key metrics performance that clearly reflects the caliber of combined skill and service the Scimega team of oncology experts consistently delivers, this CRO works hard at working smarter every year for over two decades.
Contributed by: Julie Martin, CEO & co-Owner