Published On: 10/23/2023

by Ewa Kleczyk, PhD, SVP, Commercial Analytics & Data Curation

Leveraging Real-World Evidence with Analytics: 3 Essential Components to Capture a 360-Degree View of Your Patient Population

Real-world evidence (RWE) is a powerful tool for drug developers. While large-scale and long-term observational studies are a boon for population health, tapping into the right combination of data sets can help industry partners zoom into specific patient populations. This aids the ability to make predictions about a group of patients, their journey, continuation, or even what the conclusion of a patient’s journey might be. It can also reveal intersections of potential patient populations and a product.

Clinical research evaluates one intervention at one moment in time. RWE is different. Done well, it can capture a 360-degree view of what’s happening to patients who share a diagnosis as they move throughout the healthcare ecosystem. The first step is data gathering. There are three key data repositories of information that can then be curated and applied to advanced analytics:

1. Electronic Medical Records (EMR) and Healthcare Claims – Gathering insurance claims data provides foundational “big picture” information surrounding diagnosis and medication interventions, including prescription medication and utilized healthcare services. EMR data is similar in that it can be gathered quickly and can provide high-level information about clinicians’ decisions and practice patterns. EMR and claims data collection and analysis were critical during COVID-19 when the medical community was searching for clues about risk factors and mortality. Large-scale data analysis helped provide early snapshots of how the virus behaved and in whom. This is essential information but lacks detail when it comes to areas like compliance or confounding factors that influence medication adherence over time, or when looking at rare diseases.
2. Patient-Generated Health Data (PGHD) – The next level of data granularity comes with aggregating consented Patient-Reported Outcomes (PRO) measures, surveys and questionnaires. PGHD provides a look into treatment decisions that are currently being made by physicians in a real-world setting as a result of patient profiles or the drug itself – as these decisions are being made. Having access to real-time decisions can better help inform R&D investment as researchers look ahead and plan for rigorous clinical trials. PGHD can also be a rich source of competitive information in terms of how drugs are being used in real-world practice at a much higher level of granularity compared to claims data. The unstructured data and notes associated with PGHD provide the color commentary to the nuts and bolts of EMR and insurance claims data.
3. Biorepository Data – As more industry partners leverage RWE to help inform clinical trial design, a biorepository collection that includes whole blood, serum, plasma, saliva, tissue and tape strips can allow a researcher to retrospectively genotype a robust patient population. Samples can be collected via an IRB-approved protocol and linked to de-identified clinically validated data derived from patient medical records and PRO measures. This can provide guidance at a critical time of a drug’s trajectory in terms of defining further research needs and potential patient populations.

Individually, these components provide important parts of the patient journey. Combined and analyzed, they create a powerful and clear picture of potential pathways for a medication to best meet the needs of a patient population. 

Longitudinal patient registries are living, breathing cohorts that continue to evolve with growing patient populations and new treatments entering the market. As researchers well know, good data often generates new questions. When analytics are applied and fully leveraged to include these three key components, sponsors need to be able to interact with the findings in a dynamic way.

Real-world evidence leader Target RWE recently launched analytical tools to do just that, called Syndicated Science™ Insights (SSI) solutions. SSI solutions aim to address research hypotheses and are agnostic to the type of data source – enabling the use of claims, EMR and PRO data, biospecimens and other linked data sources. Each solution contains rich, statistically sound scientific content and highly interactive data visualizations that allow ad hoc stratification analyses, such as disease progression in defined patient populations. All content can be updated, edited and revised over time to accommodate changing study questions, additional data, and evolving healthcare guidance. Importantly, sponsors can return to the data set to ask new questions in different ways to see what the data truly reveals.

The industry has debated the merits of EMRs vs. claims data. But, combined with the power of PGHD and biospecimens, it doesn’t have to be one or the other, all or nothing. Utilizing all available sources of information with sophisticated analytics can create a total picture that allows for inferences and predictions. RWE can reveal insights about a potential indication, which can in turn inform clinical research programs for an investigational drug or decisions regarding the path forward for a drug on the market. While none of us have a crystal ball for the future, drawing on a deep and broad dataset with analytical capabilities can help industry partners confidently advance their R&D plans.

To learn more about how you can tap into custom real-world evidence solutions, contact us at info@targetrwe.com.