Dr. Winson Cheung: Perspectives on RWE, Now and in the Future
January 21, 2026
Real-world evidence (RWE) helps us to understand how drugs and medical interventions perform in real life, by leveraging data sources outside of clinical trials. In early 2020, RWE was becoming established as a valuable data source, and the focus was shifting to how RWE can support better patient outcomes, better-informed healthcare decision-making, and better bridging of evidence gaps.
To make sense of that changing conversation, 20Sense spoke with RWE guru Dr. Winson Cheung, Professor of Medicine at the University of Calgary, and Director of the Oncology Outcomes (O2) RWE research program. Our initial conversation was part of the April 2020 issue: At the epicentre of real-world data: A conversation with Dr. Winson Cheung [Issue 12, April 2020]. Read the original article here. Since then, he’s only gone deeper into the RWE world. We checked in with Dr. Cheung to see how that world has changed and where he hopes things might go from here.
What trends have you seen in RWE over the last 10 years?
We’ve certainly gotten a lot busier in the RWE world! In any given disease, about 10% of potential patients are aligned with clinical trial populations and protocols, but the other 90% are not. I think payers, hospital administrators, and clinicians are increasingly becoming aware that we have to evaluate these real-world people in a more complete and detailed fashion.
Pharmaceutical companies have also been putting more investment, interest, and creativity into how they use RWE. Many of their studies are now designed to have synthetic control arms, which match a single-arm clinical trial with a real-world population to create a comparison against existing treatment options. Those studies require a longer and more deliberate planning process, which feeds into another trend – companies are thinking further ahead and involving groups like mine a lot earlier. In the past, companies would often wait until they presented their main trial results before starting to generate RWE to support their health technology assessment submission, which usually gave us a runway of just a few months. Now, some companies are approaching us a year or two before they even report the trial. It’s become more of a collaboration with industry partners, where they can tap into our experience and perspective, and we can develop ideas and plans for RWE generation together.
When we last spoke, you hoped that RWE could start playing a bigger role in healthcare decision-making. How is that going now?
I think there's been good progress over the last 10 years. Decision-making bodies like CDA-AMC and Health Canada are now more actively engaged with RWE, and they expect it to be part of submissions. It may or may not change the eventual decision, but at least they’re requesting and considering it. And the trend toward integrating RWE into clinical trials at an earlier stage is helping there, too – now that we’re working with a runway of years rather than months, the evidence we produce is more aligned with the agencies’ expectations and standards, so it’s creating more of a positive feedback loop.
“One blue sky idea is to figure out in advance how we can pool data from across Canada. Right now, each province is generally its own silo.”
Dr. Winson Cheung Director, Oncology Outcomes (O2) Research Program
Can you share an example of how RWE is making a difference in decision-making?
We recently published a study leveraging a patient support program for pemigatinib in cholangiocarcinoma.12 CDA-AMC initially ruled against funding the drug, because the available clinical trial evidence was quite weak. Despite this, patient access was made available through the patient support program, and we were able to collect and report on the clinical outcomes and experiences of 30 patients. The company then reapplied to CDA-AMC with a comprehensive evidence package that included findings from our RWE study, along with information from non-Canadian studies and physician and patient advocacy letters. The RWE was an important piece of the overall picture because it provided data from the Canadian context. CDA-AMC then made a positive recommendation, and now pemigatinib is funded for cholangiocarcinoma. RWE doesn’t replace an RCT per se, but it’s always encouraging when it plays a role in informing decisions and, ultimately, helping patients.
What are your hopes for the next 10 years in the world of RWE?
My philosophy is, earlier is always better. It would be great if RWE is thought of even earlier in the process, when RCTs are being planned, to give us more opportunities for engagement.
I’d like to see companies collaborating to look at broader clinical questions, in a less product-specific way – for example, an RWE study on adjuvant treatment in breast cancer, covering all the drugs in a given class. I find that more meaningful than separate RWE studies on each drug, because it benefits all the different products and companies. I think people are used to product-specific studies because clinical trials work that way, but it’s not very efficient. RWE should be conceived and operationalized differently because available data sources allow us to approach a clinical question more broadly.
One “blue sky” idea is to figure out in advance how we can pool data from across Canada. Right now, each province is generally its own silo. There's been lots of talk about having one national dataset, but progress has been slow. It might not be realistic right now, but I would like to see more effort toward that – I think it’s a very important goal.
We should also work on building our overall capacity, both now and for the future. Across the country, there are many methodologists and other non-clinicians who work in RWE, but only two or three clinicians who devote their careers to data sciences. If we can get more clinicians involved, we’ll be more able to design RWE studies that provide the layers and context that payers want to see. I would love to see more fellowships and opportunities for trainees or junior faculty who want to develop their academic and research programs in RWE. Instead of just three of us, there could be two dozen – and if the demand for RWE keeps expanding, we’ll really need them!
References
12. Ding PQ, et al. Pemigatinib in the Real-World Management of Cholangiocarcinoma Through a Canadian Patient Support Program. Curr Oncol 2025 Jul 16;32(7):405.