The NACTRC Real-World Evidence Unit brings together multidisciplinary teams to design and conduct research projects that generate high-quality real-world evidence.
“Real-world evidence is all of the information we capture about patients as they go through the health care system,” says Marni Devlin Moses, Associate Director of the Real World Evidence Unit. “It can include anything from the electronic medical record to pharmaceutical information… anything really outside of clinical trials.”
This real-world data provides the evidence to show patients, payers, and practitioners the value of treatments and services based on actual health outcomes and care costs.
“Alberta has a unique opportunity,” says Dr. Justin Ezekowitz, a cardiologist at the University of Alberta. “We have a very organized health care system that is first in class in many aspects of it. We have a large degree of cohesion in what we want to study and how we want to study it. We have large data sets or information we can collect on patients and across Alberta.”
By using millions of patient experiences, we can see how treatments perform in the real world and make more informed health care decisions.
NACTRC Centre Director Dr. Lawrence Richer says, “We have a health service provider in Alberta Health Services that’s very committed to research and really wants to see research entrenched in the daily work of clinical care, that it’s truly integrated in how we deliver care, so that as we’re caring for individuals, we’re also learning.”
The Real World Evidence Unit is a research centre that works with NACTRC to design and conduct observational studies (such as cohort and case control) and pragmatic trials that harness the power of real-world health data.
The unit offers partners with industry, researchers, clinicians, patients, payers, and regulators to generate knowledge or gather evidence that guides clinical care, defines product use, and informs decision-makers.
We’re co-located with the Alberta SPOR data platform, and we work closely with them to provide a variety of opportunities to generate and complete informative studies. We’re also part of the Alberta Real World Evidence Consortium.
What is real-world evidence?
Randomized controlled trials, while the gold standard in clinical evidence, are normally conducted in a limited number of participants in a highly controlled setting. As a result, the data from these trials conducted for the purposes of meeting regulatory requirements may not adequately represent how treatments are used in the real world. Leveraging routinely collected health data in observational studies and pragmatic clinical trials can help overcome the limitations of traditional clinical trials.
Real-world evidence (also known as RWE) is information about patient health that comes from sources other than standard clinical trials and research. This often takes the form of patient records and data found in health databases, insurance claims, and even medical apps and personal devices. Real-world evidence helps evaluate and compare the value of treatments and services based on actual health outcomes and care costs.
Why does real-world evidence matter?
Public payers and evidence assessment groups need to provide care, technologies, and outcomes that serve the needs of patients — all while working within a strict budget.
Real-world evidence can demonstrate the true value of medicines for both patients and the health system. Applied in this context, it can inform therapeutic development, health care system and outcomes research, effectiveness studies, and patient care to improve quality and safety.
Currently, regulatory bodies accept RWE studies in addition to clinical trials evidence. However, as administrative and clinical databases improve and analytic methods become more robust and sophisticated, real world evidence may soon be required as part of the regulatory approval process.
Why come to Alberta for real-world evidence studies?
We have a single-payer health care system.
Alberta is home to Canada’s first and largest fully integrated health care system: Alberta Health Services. AHS serves Alberta’s diverse and fast-growing population of 4.2 million people. Because we have one health care system, real-world health data can be sourced from many population-level databases, including the following.
- Clinical information systems (Connect Care)
- Ambulatory care (e.g., emergency, day surgery)
- Inpatient information (e.g., Discharge Abstract Database, hospital morbidity)
- Practitioner claims
- Population registry (e.g., demographic and geographic information)
- Alberta Blue Cross pharmacy claims
- Pharmaceutical Information Network (for patient drug use summaries)
- Vital statistics (e.g., births and deaths)
- Disease registries
- Other collected data (e.g., patient-reported outcomes, practical clinical trials)
We have internationally recognized researchers.
In partnership with the University of Alberta and provincial stakeholders through the Real World Evidence Consortium, the RWE Unit works with a network of experts that includes clinicians, methodologists, analysts, health economists, and policy makers in many different disciplines.
We bring experts together to create agile, focused teams specific to your needs. In addition, Artificial Intelligence (AI) and machine learning is an area of strength at the University of Alberta. New analytical approaches in the data sciences can be leveraged in developing RWE from health data.