The design of oncology clinical trials has long been constrained by the reliance on randomized controlled trials, which, while scientifically rigorous, often entail high costs, long timelines, and limited patient access. N-Power Medicine has now introduced what it describes as the first Prospective External Control Arm (ProECA) platform, developed in collaboration with community oncology practices, to address these challenges.
Unlike retrospective external control arms, commonly derived from electronic health records or historical trial datasets, the ProECA is embedded prospectively within routine clinical care. Central to this approach is the company’s Kaleido Registry™, an AI-enabled, human-curated data platform integrated across a network of more than 1,000 oncologists. To date, over 13,000 patients have consented to participate. Data capture is structured to align with the methodological standards of interventional trials, including prospective eligibility screening, systematic biomarker testing, and standardized imaging schedules to support endpoint assessment.
The developers of the platform suggest that the approach could reduce patient enrollment requirements for interventional arms by as much as 50%, shorten development timelines by 6–12 months, and yield significant cost efficiencies. Importantly, the ProECA design aspires to create a living synthetic control arm that can evolve alongside ongoing trials, potentially increasing both statistical power and external validity.
Early deployments of the ProECA are underway in collaboration with pharmaceutical partners. While the model is currently being applied in early-phase oncology studies, proponents anticipate its eventual integration into regulatory-grade submissions. If validated, this approach could expand access to trial participation, particularly in community settings where the majority of cancer patients are treated but historically underrepresented in research.
Commenting on the launch, Mark Lee, M.D., Ph.D., Co-Founder and CEO of N-Power Medicine, described the effort as a step toward an ecosystem where “every cancer patient can participate in research.”
Geoffrey Duyk, M.D., Ph.D., CEO of Grove Biopharma, noted that the generation of trial-quality controls directly from real-world practice may represent a more efficient path “from discovery to delivery” in oncology drug development.