Real-world data can be obtained by looking at how medicines or devices perform in typical clinical practice or select groups of patients and can be collected from sources such as health insurance or payments claims data, electronic health records, laboratory data, registry data and patient self-reported data.
As Johnson & Johnson’s Vice President and Global Head of Epidemiology, Jesse Berlin, Sc.D. and his team study real-world evidence that will benefit patients and consumers who use the company’s products every day. Here Jesse provides a closer look at how Johnson & Johnson is augmenting clinical trial data with data from real-world clinical practice to improve care for patients.
Q:
How are real-world data, or evidence, different than the statistics we hear about every day?
A:
Real-world data are collected routinely in the context of everyday medical encounters. Sometimes we capture data from patient medical records; other times we might analyze billing records to see if treatment with a medicine or use of a device in a surgical procedure resulted in improved outcomes over time, relative to another product for the same condition. We also help address questions about potential cost savings.
We can do predictive modeling with real-world data. There are at least two ways in which predictions can be used. One involves identifying a group of people who have a higher probability of developing a particular disease, compared with the general population. Doing this successfully would help with determining what the target population would be for preventing the onset of that disease. A second use of prediction is to ask questions to better understand who’s more likely to have a favorable (or unfavorable) response to treatment. Ideally, we want to increase the probability that a patient is going to benefit from a treatment and decrease the probability that a patient will experience harm from using the product.
Q:
Why are real-world data important in medical development?
A:
It’s important to understand the natural history of disease – what happens to someone once they’re diagnosed with a medical condition. Do they get better; do they have favorable responses to therapy? What adverse events do patients have, and what are the characteristics of people who don’t seem to be getting treated effectively, who don’t seem to be getting relief? That type of information can help us to identify an unmet medical need.
Gathering health economic data for payers or insurance claims is another important component. As we move to reimbursement systems that depend on outcomes, this kind of information becomes important for everyone. This is a focus of the Epidemiology team working on medical devices.
And, central to our mission, we spend most of our time looking at safety questions. We use different methods and different sources of data to try to understand safety questions. We view safety as our primary responsibility, and we strive to be proactive with those types of questions. In a given year, we might generate 50-100 publications.
Q:
How is the approach that Johnson & Johnson takes in generating real-world evidence different or unique?
A:
We spend a lot of time developing the science of epidemiology and we are among the industry leaders in that activity. We’ve helped develop statistical and visualization software programs that allow us to work very efficiently and quickly with real world data. We can now use these to perform many comparisons rather than doing studies more slowly and one at a time. This is a very novel approach that we’re evaluating. You can get a lot of information this way, looking at any comparison for any outcome. And we’re working with internal and external stakeholders to figure out what is the best and most appropriate way to move this forward.
Transparency is a large part of our mission. Once we write a plan or a protocol for a study, we’re dedicated to disclosing the results. Our intent is always to publish. However, if we can’t find a way to publish the results, then we will disclose them publicly in some other way.
A major advantage for our team is that Epidemiology sits within the Office of the Chief Medical Officer. This allows us to focus on medical and safety questions that are most relevant and important for patients and consumers.