New research explores the feasibility of EHR-integrated patient identification, enrollment, and data collection to support post-approval studies in routine clinical care.

‍Citation

Ghanim, M.T., Sanchez, D., Dykas, C. et al. Feasibility assessment of an EHR-integrated research platform for prospective data collection in community oncology practice. npj Health Syst. 3, 10 (2026). https://doi.org/10.1038/s44401-025-00066-9

Overview

New research sponsored by Johnson & Johnson highlights the feasibility of a technology-enabled, EHR-embedded platform for generating evidence in post-marketing oncology studies. Prospective, post-approval studies are essential for understanding how cancer therapies perform in real-world clinical practice. Yet traditional research models often rely on manual data collection and intensive processes that are difficult to sustain, particularly in community oncology settings where most patients receive care.

A newly published pilot study, co-authored by Flatiron Health’s Clinical Research business prior to its acquisition by Paradigm Health, evaluates the feasibility of using an EHR-integrated research platform to support prospective research in community oncology practices. The study explores whether EHR-embedded technology and workflows can streamline data collection and support patient identification and enrollment, all while preserving the data quality required for clinical decision-making and captured with completeness that gives sponsors confidence that they have limited missing data.

Over the course of the study, patients were enrolled across multiple U.S. community oncology sites, with participation reflecting the diversity of populations treated in routine care. The platform enabled high data completeness, extensive use of automated data transfer, and timely data availability, demonstrating that EHR-integrated approaches can be operationalized in community settings to support prospective research without disrupting routine care delivery.

Why This Matters

Expanding access to clinical research beyond academic centers is critical for generating evidence that reflects real-world patient populations and clinical practice. However, operational burden, limited research infrastructure, and complex data collection requirements have historically limited participation by community oncology sites.

This research highlights the potential of EHR-integrated platforms to reduce these barriers by aligning research processes with existing clinical workflows. By minimizing manual data entry and centralizing key research activities, this approach can enable broader site participation, support more inclusive and representative patient enrollment, and accelerate the generation of high-quality generalizable prospective evidence.

As regulators, payers, and clinicians call for more generalizable high quality data, scalable approaches to prospective evidence generation are increasingly important to ensure results accurately reflect the populations treated in routine care.

Looking Ahead

The insights from this study inform Paradigm Health’s approach to late-stage research execution and prospective evidence generation, designed to meet regulatory standards while reducing burden on patients and clinical teams. Prospective pragmatic studies can support post-marketing commitments, label expansion, and other medical evidence needs, while maintaining the rigor required for clinical decision-making and captured with completeness that gives sponsors confidence that they have limited missing data.