Paradigm Health announced SPIRE, Scalable Platform for Integrated Research & Evidence, a new model for post-approval and late-stage clinical studies designed to help sponsors generate prospective clinical evidence faster, more predictably, and with greater real-world representativeness.
SPIRE is built as a full-scale alternative to traditional post-approval study models. By combining pragmatic study design, streamlined patient recruitment, and EHR-integrated data capture across a network of research-ready community and academic sites, SPIRE enables sponsors to run studies that are better aligned to routine care while reducing burden on research staff and patients.
Post-approval evidence generation has often forced sponsors to choose between speed, rigor, and representativeness. SPIRE is designed to change that; maintaining rigor while leveraging technology and study design to reduce burden and accelerate recruitment. The platform supports key regulatory objectives including label expansion, post-marketing commitments and requirements, and other late-stage evidence needs by making it easier to conduct prospective studies with highly pragmatic designs that better reflect routine care.
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“Post-approval studies should not require sponsors and providers to sacrifice scientific value for operational feasibility,” said Kent Thoelke, CEO of Paradigm Health. “SPIRE brings research directly into the flow of care with pragmatic protocols, embedded recruitment, and EHR-integrated execution, helping generate the high-quality evidence sponsors need while expanding access to more representative patient populations.”
SPIRE’s model has already been used by top pharmaceutical companies in late-phase studies, including in a post-approval trial conducted at four community oncology practices to evaluate infusion-related adverse events for multiple myeloma patients treated with an FDA-approved therapy. Researchers published an assessment of the quality of data captured using an eSource solution and found that the tech-enabled model could transfer a large volume of high-quality data, reducing time for data cleaning and clarification, and rapidly enrolling a representative patient population.
Paradigm Health, along with a pharmaceutical sponsor and a team of multi-site researchers, will present another use of the SPIRE model at the American Society for Clinical Oncology’s (ASCO) Annual Meeting on June 1, 2026. The presentation will highlight SPIRE’s operational benefits in a poster 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.”
Source: PRNewswire