OMNY Health, the leading healthcare ecosystem for compliant real-world data insights at scale, today announced it has become the first electronic health record (EHR) company to offer its real world data (RWD) dataset on Datavant Connect powered by AWS Clean Rooms through its Lighthouse Partner Program.
The pharmaceutical industry is rapidly embracing real-world evidence (RWE) to accelerate drug development and regulatory approvals. External control arms (ECAs), built using real-world data (RWD), are transforming clinical trials by offering an alternative to traditional placebo groups. By reducing recruitment burdens, increasing statistical power, and aligning with regulatory expectations, ECAs have the potential to redefine late-stage drug development.
OMNY Health is at the forefront of this shift, providing research-ready EHR datasets that seamlessly integrate into clinical trial designs. Our recent study demonstrates how EHR-derived control arms can effectively mirror traditional placebo groups, offering a robust and scalable solution for regulatory submissions.
To evaluate the feasibility of an ECA in a late-stage clinical trial, OMNY Health leveraged six specialty dermatology networks and six integrated delivery networks (2017-2024) from its real-world data platform. The study constructed an ECA for the Phase 3 POETYK PSO-1 trial, which evaluated deucravacitinib versus placebo for moderate-to-severe plaque psoriasis.
The ECA was built using precise patient selection criteria that ensured alignment with the trial’s placebo group. Patients were included if they met physician global assessment (PGA) score eligibility, ensuring comparable disease severity. Baseline treatment history was carefully controlled, and topical medication use was restricted prior to the index severity visit to reflect treatment-naïve status. By tracking patients longitudinally, we assessed week-16 outcomes using structured EHR data, mirroring the trial’s methodology.
While some demographic differences were observed—ECA patients were older, more likely to be female, and had a different racial distribution compared to the placebo arm—the disease severity and baseline clinical characteristics were well matched.
The real-world ECA demonstrated a significantly higher response rate compared to the traditional placebo arm, reinforcing its validity as a comparator.
One notable finding was racial disparities in achieving the primary endpoint within the ECA, suggesting that differences in patient demographics between the ECA and placebo group may have contributed to the observed differences in response rates. Further research could explore adjustments such as population weighting to refine ECA comparability even further.
These results confirm that OMNY Health’s real-world dataset can be used to generate ECAs that replicate clinical trial placebo groups, while also revealing new insights into patient diversity, treatment history, and long-term outcomes.
Traditional clinical trials face high recruitment costs, ethical concerns over placebo use, and long enrollment timelines. OMNY Health helps to eliminate these barriers by offering regulatory-grade EHR data that aligns with clinical trial endpoints.
With 85M+ patients, 1B+ encounters, and 4B+ unstructured clinical notes, our dataset provides a scalable and statistically powerful alternative to traditional control groups. By incorporating structured disease severity scores, prescribing patterns, and physician-reported outcomes, our ECAs offer more efficient and cost-effective alternative to prospectively collected placebo data.
Beyond reducing recruitment time, OMNY Health’s real-world ECAs improve trial generalizability, capturing diverse patient populations often underrepresented in traditional studies. As the FDA increasingly endorses RWD for regulatory decision-making, the ability to integrate ECA’s into pivotal trials is becoming a competitive advantage for pharmaceutical companies.
Pruritus, or chronic itch, is one of the most common symptoms reported in dermatology, yet real-world treatment patterns remain poorly characterized. While topical therapies are typically the first-line approach, severe cases often require systemic interventions. But how do clinicians determine when to escalate therapy? OMNY Health conducted a real-world evidence study leveraging research-ready EHR data from six specialty dermatology networks to examine how itch intensity, a critical but underutilized measure, influences real-world prescribing patterns. By integrating structured and unstructured clinical data, OMNY provides new insights into the relationship between symptom severity and treatment decisions.
While pruritus is a symptom, its severity can significantly impact quality of life and treatment choices. This study focused on patients with a documented 10-point itch intensity score, captured through physician assessments and patient-reported outcomes. The dataset included 7,330 patients with 8,115 encounters, capturing the following structured severity measures:
By leveraging EHR-derived severity assessments, the study provides a more granular understanding of how treatment decisions align with symptom burden.
Findings revealed a clear relationship between itch severity and systemic therapy use, while topical therapies were prescribed at consistent rates across all levels of severity.
The increasing use of sedative antihistamines in severe cases suggests a reliance on limited systemic options, leaving a gap in alternative therapies for patients with refractory pruritus.
The underutilization of structured itch severity scores in real-world studies has historically limited the ability to quantify treatment impact. Our findings reinforce why itch intensity should be a standard measure in both clinical decision-making and drug development. For clinicians, understanding real-world prescribing trends tied to symptom severity can optimize treatment pathways and inform escalation decisions. For researchers and trial sponsors, itch intensity scores provide an opportunity to refine patient segmentation, support cohort identification, and assess real-world treatment responses. For drug developers, the limited use of alternative systemic therapies highlights a need for novel treatments, particularly for patients with refractory pruritus.
This EHR-based study provides new insights into how structured itch intensity measures correlate with real-world prescribing behavior. By integrating structured severity assessments with prescribing data, OMNY Health’s research-ready datasets offer a unique lens into treatment trends, patient stratification, and disease burden.
