Personalized Healthcare (PHC) is transforming the healthcare ecosystem with a focus on data-driven, customized care for the individual patient. A key element of realizing PHC is leveraging data that is collected throughout a patient’s journey, known as real-world data (RWD). RWD can offer meaningful insights that go beyond traditional data generated through controlled clinical trials, to understand the full picture of a person’s health profile and help guide clinical decision making. Despite the increasing importance of this data in the healthcare landscape, there remains work to be done in Canada to ensure clinicians and institutions have the experience and tools they need, and that patients are empowered, to leverage the full potential of RWD and make informed decisions.
PHC and the integration of RWD into the Canadian healthcare ecosystem are key priorities for Roche, and we are committed to advancing this transformation. But we know we cannot accomplish this on our own. With the current opportunities and challenges in healthcare, strong collaborations are more critical than ever before. That’s why we are working with Oncology Outcomes (O2), a highly experienced resource group dedicated to real-world evidence data generation and integration. Through this collaboration, Roche and O2 will work together to increase RWD acceptability and accessibility across the Canadian ecosystem.
Dr. Winson Cheung, co-founder of O2, and Jodi Garner, Strategic Collaborations Lead, Roche Canada, share their thoughts on the potential impact of RWD in Canada and how this collaboration will help drive it forward.
Why is RWD an important aspect to improve the Canadian healthcare system?
Jodi: Clinical trial data is considered the gold standard of evidence to determine the best treatment choices, but they only speak to a sliver of the population that a drug or medical device might be used in, as clinical trials are often done in a controlled setting. As new products and health services integrate into clinical practice, we have the ability to use RWD to see how a more general population responds in the real world. This helps to uncover new insights that will support our healthcare ecosystem make better and faster decisions.
Dr. Cheung: Conventional evaluation of new drugs or cancer care systems have relied solely on findings from clinical trials. While clinical trials remain important, they do not always tell the full story because participants typically represent the youngest and fittest patients. There is a significant data gap, especially with respect to the majority that cannot participate in these trials. RWD can help inform and guide healthcare strategies related to the general population. Payers and decision-makers have also become aware that RWD can be a strong complement to clinical trials. There is room for both types of evidence generation and each serves a different purpose.
What are the biggest opportunities you see in RWD collection and use?
Jodi: RWD has the potential to help in real time fact-based clinical decision making, reimbursement and regulatory considerations, and guiding clinical trial design as just a few examples. Patients could also have the ability to access their own health data, empowering them to make informed decisions alongside their healthcare team.
Dr. Cheung: Data is getting more complex and it is increasingly difficult and resource-intensive to extract information in a way that can be properly analyzed. I think there is an opportunity to leverage technical advances (e.g. AI, machine learning) to streamline the data curation process.
What are the biggest challenges in the collection and use of RWD? How are these challenges currently being addressed?
Jodi: Access to data is a significant challenge in healthcare. In Canada we have a fragmented system across individual institutions and provinces that makes data extraction and integration with other systems extremely difficult, expensive and time consuming. Data records are also often outdated and show a single point in time in a patient's journey, so it’s difficult to make real time decisions on the best treatment path. At Roche we have been working with several institutions to help them build internal capabilities that streamline the collection process and harness machine learning/AI technologies to better structure that data.
Dr. Cheung: One of the biggest challenges with RWD is the array of data sources that can be used. While the breadth and scope of available data can be strengths, there are also limitations. When conducting real-world evidence (RWE) generation, it’s also critical to have a team composed of experienced data scientists who can apply the right statistical approaches when structuring and analyzing the data, as well as clinicians who can provide important clinical context. To this end, we are developing a training program to educate teams on the best ways to work with RWD so that the evidence generation process can be as scientifically rigorous as possible.
What do you hope to achieve through the Roche-O2 collaboration?
Jodi: We have worked closely with the O2 group to refine what this collaboration will focus on based on aligned priorities and opportunities to leverage each other's experience and capabilities. We hope to grow Canada’s expertise in RWD with training for the next generation of clinicians, collaborate on activities that will drive RWE acceptability with our regulatory and funding bodies, and continue to explore innovative methodologies for data analysis. Working closely with O2 will allow both of our teams to learn from each other and allow us to both achieve more than we would independently. We believe this is the way of the future. If we want to maximize our contributions and ability to shape a better healthcare system in Canada and globally, it will only happen if we start to work holistically.
Dr. Cheung: “It takes a village” is an accurate way to describe the current state of RWE generation - we need a team effort to draw attention to its growing value. A major benefit of this collaboration is that we can think outside the box and devise plans that shape the use and impact of real-world evidence in Canada. In addition to conducting conventional RWE projects, O2 will work with Roche to co-develop new statistical methods and innovative study designs that fully leverage the breadth of data available and help elevate the value of this evidence to relevant stakeholders and improve the way RWE is perceived and implemented. This type of work is currently lacking in Canada and it has the potential to shift the way that decision- and policy-makers interpret and use real-world evidence. In working with Roche and other industry partners, and by leveraging Roche’s extensive global network, the hope is that the reach of our efforts will extend beyond Canadian borders.