Paradigm Health Implements New Clinical Trial Solution to Support Observational Study Presented at ASCO

Paradigm Health's Scalable Platform for Integrated Research and Evidence (SPIRE) helps trial sponsors generate high-quality clinical trial data across community healthcare practices

Columbus, Ohio and CHICAGO, June 1, 2026 /PRNewswire/ -- Paradigm Health today announced its role in the execution of a multicenter, hybrid, observational post-marketing commitment study in the United States evaluating an FDA-approved therapy in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors. The trial uses Paradigm Health's SPIRE model as the technology-enabled infrastructure to accelerate end-to-end trial operations, from trial design, site selection, patient identification, and data collection, to efficient evidence generation. A principal investigator from Florida Cancer Specialists & Research Institute (FCS) presented a poster on the trial design and operations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1. The abstract (TPS11202) is titled A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 3+ solid tumors: DESTINY-PanTumor04. Study authors also include researchers from Paradigm Health, AstraZeneca (trial sponsor), and Daiichi Sankyo.

The SPIRE infrastructure uses the same data collection technology that underpins the proof-of-concept currently underway with the U.S. Food & Drug Administration (FDA) to evaluate the implementation of Real-Time Clinical Trials.

The trial was designed to track approximately 100 patients at up to 30 U.S. locations, from community practices to academic medical centers. The SPIRE model provides the end-to-end infrastructure that can help sponsors design pragmatic trials and embed into study sites to automate data collection, identify eligible patients faster, and expedite transmission of analysis-ready data to sponsors. By streamlining these labor-intensive steps, SPIRE enables researchers across community settings, hospitals, and academic medical centers to participate in the same late-phase clinical trials.

"This research shows how SPIRE can be used in a broad range of healthcare settings. Already, 13 community oncology centers are participating in this study," said Kent Thoelke, Founder and CEO of Paradigm Health. "By connecting fragmented clinical databases and other data sources, we can lower the operational burden for research staff while maintaining the completeness and accuracy needed by trial sponsors. This helps make clinical research feasible for more study sites, ultimately, opening research up to more patients."

The poster highlights the study's pragmatic trial elements achieved through the SPIRE model, including broad eligibility criteria, routine clinical practice settings, integration of primary and secondary sources into study data collection, and pragmatic endpoints. Paradigm Health's SPIRE model optimizes the trial design, site selection, and simplification of patient identification and enrollment, improving data accuracy and completeness, all aimed at making clinical trial workflows feasible for more sites. SPIRE-enabled pragmatic prospective studies are uniquely positioned to evaluate effectiveness in routine care and enroll patient populations that are reflective of real-world healthcare settings.

"Observational and late-phase studies require the technological infrastructure to operate within clinical care delivery, and my team at FCS is at the forefront of this technological modernization," said Lucio Gordan, President and Managing Physician at FCS. "Paradigm Health's SPIRE was designed to help trial sites align clinical workflows with research operations, expediting analysis-ready data capture without increasing burden on providers or site staff."

About Paradigm Health

Paradigm Health has engineered an AI-powered platform to make clinical trials more accessible and efficient, so that patients, researchers, and study sponsors can maximize the impact of clinical research. Incubated by ARCH Venture Partners and backed by leading healthcare and life sciences investors, Paradigm Health aims to break down barriers across the trial ecosystem through one seamless infrastructure implemented at healthcare provider organizations, bringing potentially life-saving therapies to patients faster. For more information, visit https://www.paradigmhealth.ai.

About SPIRE

Scalable Platform for Integrated Research and Evidence (SPIRE) is an end-to-end, technology-enabled alternative to traditional CRO-led approaches for prospective, pragmatic studies, particularly for approved products and products nearing approval with established safety profiles.

The solution combines:

• EHR-integrated technology embedded directly into patient visits, in community, rural, and academic settings across 46 of 50 states
• Data-driven study design and site selection informed by care patterns and site capabilities
• Full-service study conduct support across site selection, startup, enrollment, data management, safety, and closeout

SPIRE Intended Use Cases

SPIRE is intended for prospective, pragmatic U.S. studies for assets that are approved of nearing approval, including:

• Post-marketing requirements and commitments with observational designs
• Phase IV safety and/or effectiveness
• Label expansion
• Comparative effectiveness
• Prospective registries and external control arms
• Hybrid studies incorporating randomized and pragmatic elements

About Paradigm Health's Collaboration with FDA on Real-Time Clinical Trials

In April 2026, Paradigm Health announced a landmark research collaboration with the FDA focused on advancing a new model to accelerate clinical trial execution and regulatory review. The model uses Paradigm Health's technology-enabled Study Conduct platform to allow real-time review by the FDA, by automating data collection and analysis, and streamlining the reporting of key safety and efficacy signals to trial sponsors and the FDA.

SOURCE Paradigm Health, Inc.