N-Power Medicine Launches Industry’s First Prospective External Control Arm Platform to Dramatically Accelerate Oncology Drug Development and Reduce Reliance on Randomization

REDWOOD CITY, Calif.--(BUSINESS WIRE)--N-Power Medicine, a company reimagining oncology drug development, today announced the launch of the industry’s first Prospective External Control Arm (ProECA) platform for pharmaceutical and biotechnology partners. Designed to reduce reliance on traditional randomized clinical trials, this groundbreaking model aims to cut patient enrollment requirements by up to 50 percent, shorten trial timelines by 6-12 months, and save tens to hundreds of millions of dollars per development program, while expanding opportunities for more patients to participate in cancer research.

At the core of the ProECA is N-Power’s Kaleido Registry™, a proprietary AI-enabled, human-in-the-loop data engine, embedded directly into routine care within the N-Power Network, which has access to more than 1,000 community oncologists. Patients consented in Kaleido participate in a prospective program to generate trial-grade data, specifically designed to overcome the limitations of retrospective external controls. ProECA is intentionally designed to mirror the structure and scientific rigor of clinical trials, including eligibility criteria, prognostic covariates, timed biomarker testing, and the standardized imaging and imaging schedules required for clinical trial endpoints. The ultimate goal is a living, evergreen synthetic control arm that can be rigorously incorporated into faster, less expensive clinical development strategies.

“This is a pivotal shift in how oncology trials are designed and executed,” said Mark Lee, M.D., Ph.D., Co-Founder and CEO of N-Power Medicine. “With ProECA and Kaleido, we are creating an ecosystem where every cancer patient can participate in research, especially in the community setting where the vast majority of patients receive their care. This new model will impact early-phase development today on the way to regulatory applications in the future, accelerating the path for life-saving medicines to get to patients who need them.”

Industry leaders see this as a transformative moment. “The ability to generate trial-quality external controls from real-time clinical care will redefine oncology research,” said Geoffrey Duyk, M.D., Ph.D., CEO of Grove Biopharma. “Once widely adopted, this model will be a far more efficient path from discovery to delivery, and unlocks broader access to clinical trials of innovative therapies and more cost-effective patient care overall.”

N-Power has already enrolled more than 13,000 patients into the Kaleido Registry and launched multiple collaborations with leading pharmaceutical companies, with the first ProECA deployments now underway. For drug developers, the model offers a path to faster, more predictable development and reduced trial costs. For patients, it means greater inclusion in research and faster access to the most transformative therapies in cancer care.

About N-Power Medicine

N-Power Medicine is redefining how oncology trials are designed and conducted. Through a national network of research-ready community practices, N-Power is building a new ecosystem that is dramatically increasing clinical trial participation, shortening drug development timelines and delivering on the promise of bringing transformative therapies to patients with cancer.

For more information visit www.npowermedicine.com and follow us on LinkedIn.