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How Integrated Real-World Data Leads to More Meaningful Results

In order to understand the current state of the healthcare system it is essential to have comprehensive sources of real-world and integrated data linked with data from across the healthcare ecosystem.

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A painter who uses just a few colors will be limited in the distinctness of paintings they can create, while a painter that uses a variety of colors can create art that is more elegant. The same is true for health outcomes research. A researcher who only includes a narrow patient population, or only captures certain types of data, will be limited in the types of analyses they can perform and the relevance to a broad population.

Linking data across the healthcare system

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

In order to understand the current state of the healthcare system it is essential to have comprehensive sources of real-world and integrated data linked with data from across the healthcare ecosystem, including laboratory results, mortality, electronic health records (EHR), race and ethnicity data, social determinants of health data, and vaccination records.

Such integrated real-world data that represent a broad patient population and span the many ways they touch the healthcare system – from electronic health records to insurance claims to government programs – are critical for developing a more accurate picture of people’s health and understanding of how treatments perform in everyday practice.

Insights gathered from real-world data

This real-world integrated data can help researchers understand how treatments during pregnancy can affect outcomes for both mothers and their infants, which is notoriously difficult to study in the context of clinical trials. Pregnant women are often excluded from drug trials because of the potential risks to the developing fetus, which leaves patients and providers relying largely on animal studies when deciding whether medicines are safe to use during pregnancy.

Using real-world data from everyday clinical practice can help researchers detect rare events. One study found that first trimester exposure to a medication used for the treatment of epilepsy is associated with an increased prevalence of oral clefts. Equipped with this type of information, providers and patients have a clearer picture of the potential risks of treatment that they can weigh when deciding between their options.

A separate study found that linking Covid-19 and mpox vaccine claims to state-based immunization data better captured vaccine uptake and safety across the population, filling in demographic gaps inherent in either data source alone. Accurate vaccination rates are necessary for designing effective and equitable public health campaigns. Having a more complete picture of vaccine safety data could help to combat mistrust and hesitancy.

Health equity through real-world data

About 80% of clinical trial participants are White, followed by 10% Black, 6% Latino, 1% Asian, and 0% Native American. For cancer – a disease that overwhelmingly affects older people – the median age of clinical trial participants is almost 7 years younger than the overall disease population. This lack of representation casts doubts on the generalizability of results and compounds health inequities.

Insights generated from integrated data sets can better represent the full continuum of patients seen in everyday clinical practice, and in turn help us to understand how medicines work in more of our population. To serve this cause, data must capture a variety of social determinants of health, including educational attainment, income, living conditions, family composition, transportation, socioeconomic status, rurality, and food access. Studies using real-world integrated healthcare databases can complement rigorous clinical trials to create a clearer picture of whether medical interventions are reaching vulnerable groups and how they might be responding.

Integrated data represents the future of real-world research, enabling scientists, clinicians, payers, and patients to see how medicines perform in everyday practice and among a broad swath of the population. With this information, patients can gain more insight into how treatments work for people who look like them and providers can provide more individualized treatment recommendations.

Decades of experience and relationships with health plans allow a deep understanding of the data flow and processing, which is essential to transforming these raw assets into actionable evidence.

By using integrated data to paint a vibrantly colored portrait of human health, we can help address healthcare’s complex challenges and work toward a more just and equitable society.

Photo: ipopba, Getty Images

Mark Cziraky, PharmD, CLS is Vice President, Elevance Health, and President, Carelon Research, where he has been extensively involved with clinical and health economics, and outcomes research for more than 25 years. Mark was co-founder of Carelon Research (formerly HealthCore), where prior to becoming President, he was most recently responsible for leading Scientific Affairs and global scientific and business development at Carelon Research. He serves as a key architect in creating open-source research collaborations within the healthcare industry that allow health plans to be involved in research design and execution with various collaborating organizations.

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