Mass General Brigham Spins Out AIwithCare to Revolutionize Clinical Trial Patient Matching with AI
Key Insights
Mass General Brigham (search) has launched AIwithCare (search), a spinout company featuring RECTIFIER (search), an AI tool that significantly outperformed manual screening for clinical trial patient enrollment.
In a randomized trial of nearly 4,500 patients published in JAMA, RECTIFIER (search) achieved almost double the enrollment rate compared to traditional manual screening methods.
The AI platform has expanded to over 20 active use cases across multiple specialties including cardiology, oncology, and neurology, with demonstrated accuracy rates of 94.7% for patient referral triage.
Mass General Brigham (search) has announced the spinout of AIwithCare (search), a new company built around an artificial intelligence screening tool that has demonstrated superior performance in matching patients to clinical trials. The AI platform, called RECTIFIER (search) (RAG-Enabled Clinical Trial Infrastructure for Inclusion Exclusion Review), significantly outperformed manual screening methods in determining patient eligibility and enrollment for clinical studies.
Proven Clinical Performance
RECTIFIER (search)'s effectiveness has been validated through rigorous clinical testing. In a 2024 study published in NEJM AI, the tool more accurately identified eligible patients for a heart failure trial compared to manual screening, while operating at far lower cost than traditional methods. A subsequent randomized controlled trial of nearly 4,500 patients, published in JAMA earlier this year, demonstrated that enrollment rates using RECTIFIER were almost double those achieved through traditional manual screening.
Importantly, the JAMA study showed no significant differences in trial eligibility and enrollment rates when analyzed by patients' race, gender, and ethnicity, addressing key concerns about AI bias in healthcare applications.
Technology and Implementation
RECTIFIER (search) leverages generative AI and Retrieval-Augmented Generation (RAG) technology to screen patients' electronic health records for clinical trial eligibility criteria. The system analyzes diagnoses, key health indicators, and current or past medications, with particular strength in assessing unstructured data from clinical notes and reports that are typically inaccessible without laborious manual review.
"The tool's demonstrated ability to rapidly and accurately identify patients for studies can be a game-changer for research teams and especially for the patients who deserve timely access to clinical trials of cutting-edge therapies," said Sandy Aronson, president and Chief AI Officer of AIwithCare (search).
Expanding Clinical Applications
Since its initial development at Mass General Brigham (search)'s Accelerator for Clinical Transformation, RECTIFIER (search) has expanded to more than 20 active and onboarding use cases across research and clinical operations. The platform is now deployed across multiple specialties including cardiology, oncology, gastroenterology, neurology, pathology, and psychiatry.
Beyond clinical trials, the technology has found applications in routine clinical care. Pediatric gastroenterologists are using RECTIFIER (search) for patient referral triage with 94.7% accuracy, while achieving 98% accuracy in identifying urgent labs and symptoms within clinical notes. The Mass General Brigham (search) Population Health Service Organization, responsible for improving care for over 650,000 patients, has implemented the tool to streamline patient assessment for heart failure management programs and identify patients with elevated blood pressure for targeted interventions.
Commercial Strategy and Market Expansion
Through AIwithCare (search) and its AIwithCare Studio platform, the company plans to scale the technology to other healthcare systems, hospitals, and clinics seeking to improve patient-trial matching and enhance medical analytics capabilities.
"Licensing RECTIFIER (search) is a major milestone in our goal of delivering AI-powered solutions that improve operational workflows, enhance clinical trial efficiency and optimize care delivery pathways," said Alexander "A.J." Blood, MD, MSc, RECTIFIER research co-senior author and AIwithCare (search) CEO and co-founder.
Jane Moran, Chief Information and Data Officer at Mass General Brigham (search), emphasized the complexity of developing clinically integrated AI tools: "Building tools that fit smoothly into clinical trial workflows requires cross-functional teams with expertise in clinical practice and with technical aptitude. That includes change management, software development, information security, and product and program management. Our ability to bring all these skills together to develop AI solutions was essential."
Innovation Pipeline
RECTIFIER (search) represents the first company spun out by Mass General Brigham (search) involving a RAG AI application developed by researchers within the health system. The development emerged from collaborative efforts between the healthcare system's Digital, Personalized Medicine, Accelerator for Clinical Transformation, and Innovation groups.
Mass General Brigham (search) Innovation, which facilitated the spinout, maintains an active portfolio of more than 1,400 licenses, with over 600 new inventions disclosed and nearly 200 U.S. patents issued in the past year alone.
"Advancing AI that can streamline matching patients with clinical trials reflects our commitment to practical innovation that strengthens patient care and expands access to promising therapies," said Chris Coburn, Chief Innovation Officer at Mass General Brigham (search). "Deploying such technology more broadly could help reduce significant barriers in care delivery and ultimately accelerate clinical research."