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Office of the Chief Medical Officer

What is Real-World Evidence and How Does It Help Patients?

A Q&A with Josh Gagne, Vice President and Global Head of Epidemiology, Johnson & Johnson
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Innovative new medicines and medical technologies undergo robust safety assessments before they are made available to patients. Once they are approved by regulatory authorities and in use, real-world data are used to help us continue to evaluate the safety and effectiveness of our products in real-world settings to complement what we know from clinical trials.
 
Real-world data reflect how medicines or devices are used in typical clinical practice and can be collected from sources such as, health insurance 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, Josh Gagne and his team study real-world data to further understand the safety of our products across many different kinds of patients and clinical environments to help inform important decisions that ultimately improve care for patients.

Q:

What are real-world data and what is real-world evidence?

A:

Real-world data and real-world evidence are much more than just buzz words. They are integral to ensuring the safe and effective use of medications, vaccines, medical devices, and other healthcare products by people all around the world. Our health care systems produce large amounts of data every day—from clinical notes captured in electronic health records at hospitals and outpatient facilities, to administrative billing claims submitted by health care providers and captured by insurance programs, to data captured from other sources, such as mobile devices. These are considered “real-world data” because they are produced during delivery of routine health care services. “Real-world evidence” is the phrase we use to describe evidence that we generate by analyzing real-world data.

At Johnson & Johnson Epidemiology, we evaluate and use the highest-quality real-world data available and the most rigorous scientific methods so we can generate the most reliable real-world evidence possible from these data.

Q:

How is real-world evidence used?

A:

Researchers around the world, including those here at Johnson & Johnson, use real-world data to advance our understanding of medical products and how they impact health outcomes in the real world.

These data are translated into real-world evidence to answer important questions. For example, whether certain medical products are more likely to increase or decrease the probability of a particular health outcome, which characteristics might predict whether individuals are more or less likely to experience an outcome while using a specific medical product, and whether certain medical products have other impacts, such as reducing administrative or other medical costs. With this information, doctors and patients can make more informed decisions about care and treatment.

Q:

How do real-world data help patients and consumers?

A:

Patients and consumers routinely rely on the benefits of real-world data without necessarily realizing it. For example, real-world data analyses are a cornerstone of how Johnson & Johnson monitors the safety of our medical products as they are used in the real-world and informs decisions about our products.

Evidence generated from real-world data can also be used directly by healthcare professionals and patients to make more informed decisions about their health and the treatments that they use, such as whether one treatment is better than another. Our team is committed to generating evidence to answer the question, “What can I expect when I use this product?”

Q:

How is the approach that Johnson & Johnson takes in generating real-world evidence different or unique?

A:

At Johnson & Johnson, the safety of our products is our top priority. Our Epidemiology team sits within the Office of the Chief Medical Officer, which allows us to focus on medical and safety questions that are most relevant and important for those who use our products all around the world.

For example, we are designing and developing novel approaches to using real-world data to identify and quantify potential safety signals as early as possible, and we have developed a framework to help us better understand—in a quantitative way—how patients evaluate potential benefit-risk tradeoffs for our products.

We are also leaders in developing new methodology to advance the science of translating real-world data into reliable, and what we like to call 'regulatory-grade,' real-world evidence. And of course, transparency is a critical aspect of the work we do. We are dedicated to registering our study protocols and disclosing their results to help accelerate important research beyond Johnson & Johnson, and ultimately improve health outcomes for more people.

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