The human desire to extend life is at the heart of scientific research and discovery. As a society, we have strived to eradicate diseases and illnesses that threaten human life. The truth of the matter is that while we are living healthier, longer lives, our fight against diseases like cancer, rheumatoid arthritis and multiple sclerosis is not yet won.
As a leader in the Canadian life sciences sector, we believe that we can continue to drive improvements in human health through evidence-based medicine. Part of this focus includes bringing more clinical trials to Canada, so that Canadians may benefit from accessing novel medicines and, ultimately, contribute to the development of new ways of fighting diseases. Canada is recognized around the world for the quality and expertise of our researchers and institutions. Clinical trials contribute significantly to the Canadian economy and Roche is one of the largest investors in clinical research - in 2016, approximately 13.5% of our trials globally were conducted in Canada, which resulted in a $14.7 million investment into the Canadian economy. What makes this investment stand out is that we take a holistic approach to healthcare and personalized medicine through the development of both diagnostics and medicines, and focus our efforts on areas of high unmet medical need to have the greatest possible impact. This focus on developing personalized treatments requires us to approach our clinical research differently.
While traditional models of conducting trials have been successful to date, we believe that patients today need greater flexibility. Our approach to clinical trials needs to focus on the patient first – whether it’s through the adoption of technology that reduces clinic visits, or data collection methods that streamline real-world information without burdening the patient or their family. This is especially important for studies that evaluate novel diagnostics and medicines to treat rare diseases where the patient population is limited and where patients may have already participated in previous research.
While our global Pharmaceutical Product Development site in Canada has embedded patient-centric practices like the use of mobile home nurses and mobile devices into the design of our trials, it’s only the first step. Companies, hospitals, research institutions and government need to work closely to help bring more trials here, offering Canadians the opportunity to benefit from investigational medicines early. We also need to ensure that provincial drug reimbursement policies recognize the role of clinical trials in the care continuum to further encourage Canadians to participate in clinical research.
Developing and validating the use of new medicines is growing to be increasingly complex and expensive. For example, only 0.02% of potential cancer treatments created in the lab will ever reach patients, and bringing a medicine from research to reality can take 10-13 years. Because of our ever-evolving understanding of disease and the pace at which technology and science change, there is no longer a linear path to evaluating approaches to treatment and diagnosis through clinical trials. We are rethinking the traditional clinical trial model, exploring new ways to capitalize on the constantly growing body of scientific knowledge and provide earlier access to patients. Drug development today requires more creative, seamless ways of evaluating medicines based on progression of disease, changes in human biology, and how investigational medicines may work together to treat complex symptoms. Examples include the following:
- Umbrella trials, most often used in the area of cancer research, which assess the impact of different medicines on different genetic mutations (e.g. EGFR+, HER2+) “under the umbrella of one disease” (e.g. lung cancer), allowing researchers to identify subgroups of patients who could potentially benefit the most from a given course of treatment.
- “Basket” or “bucket” trials, which test the effect of a single medicine or treatment combination on a specific mutation across multiple cancer types regardless of where the tumour originated. Basket trials allow us to look at the effectiveness of a treatment in different tumour types and provide a unique opportunity to study rare cancers, which are underrepresented in clinical trials because of the small number of patients.
In addition to these trials, “adaptive” study designs are emerging as another promising way to look at investigational medicines. While traditional trials have a predetermined design, adaptive trials allow for parameters within the study, such as treatment regimen, study population, and sample size, to be modified at checkpoints throughout the trial, based on interim results. This approach allows clinical trials to keep pace with the latest scientific evidence without undermining the validity and integrity of the results.
Supporting Innovation Through Policy
While new approaches to clinical research can help us address some of the challenges around the speed of emerging technologies and increasing scientific knowledge, they need to be supported by strong policies to keep Canada at the forefront of medical research. As Nita Arora, head of our global Pharmaceutical Product Development site in Mississauga, explains, “We are known for great science in Canada. For our size and population distribution, it’s pretty amazing that we’re fourth globally in carrying out clinical trials. We have world-class academic institutions and hospitals, highly skilled individuals, and innovative companies. We should be proud of our unique position and scientific ecosystem and it’s important that we create an environment where we continue to remain competitive.”
In order to sustain an innovative clinical environment in Canada, we need to address barriers and cultivate partnerships. For example, we don’t yet know the impact non-linear clinical trial designs may have on our Canadian regulatory pathway, specifically how Health Canada will assess data when approving new diagnostics and medicines.
An additional area where Canada has the opportunity to become a leader is in the identification and selection of clinical trial sites that represent the full country. While we have a diverse population that lends itself well to clinical study, there is an infrastructure gap – a divide between urban and rural, large and small research institutions. It’s particularly difficult for smaller centres to conduct trials, which impacts patients in rural and remote areas. Creating Centres of Excellence in key areas across the country to help build strong networking pathways between academic centres and community practices could address this gap, supporting clinical trial awareness and recruitment, and allowing for the centralization of data analytics that support regulatory and reimbursement decisions.
Advances in our understanding of human biology bring us closer to discovering more precise, personalized approaches to treating diseases. As a country with a rich ecosystem and history of research excellence, Canada has the opportunity to play a pivotal leadership role in advancing the future of healthcare. Driving innovation-first policies will ensure this leadership and enhance our ability to compete for clinical research investments on a global stage.
October 17, 2017