The tool, RECTIFIER (RAG-Enabled Clinical Trial Infrastructure for Inclusion Exclusion Review), was first developed and studied by researchers at Mass General Brigham’s Accelerator for Clinical Transformation. Since the publications of a proof-of-concept study in June 2024 and prospective, randomized-controlled, blinded trial in February 2025, RECTIFIER’s use has continued to expand across the healthcare system, with more than 20 active and onboarding use cases in research and clinical operations, including in cardiology, oncology, gastroenterology, neurology, pathology and psychiatry.
RECTIFIER represents the first new company spun out by Mass General Brigham involving a Retrieval-Augmented Generation (RAG) AI application developed by researchers within the health system. The development and deployment of the tool was born out of a collaborative effort between the healthcare system’s Digital, Personalized Medicine, Accelerator for Clinical Transformation and Innovation groups.
Through AIwithCare, and its AIwithCare Studio platform, the researchers plan to scale this capability to other healthcare systems, hospitals and clinics seeking to match their patient populations with relevant clinical trials and support medical and operational applications with improved analytics.
"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,” said Jane Moran, Chief Information and Data Officer at Mass General Brigham. “Our ability to bring all these skills together to develop AI solutions was essential. Now that this work is complete, it will be much easier for others to deploy and benefit from the capabilities."
RECTIFIER leverages generative AI to screen a patient’s electronic health record for information that can determine their eligibility for a clinical trial such as diagnoses, key health indicators and current or past medications. The tool assesses unstructured data available in notes and reports, which are often crucial for determining trial eligibility but are typically inaccessible without a laborious manual review process from research coordinators and clinical staff.
In a 2024 study in NEJM AI, RECTIFIER was found to more accurately identify eligible patients that met a heart failure trial’s eligibility criteria when compared to manual screening, and at a far lower cost than traditional methods. A follow-up randomized trial of nearly 4,500 patients, published in JAMA earlier this year, found that the rate of enrollment using RECTIFIER for patient screening was almost double that of traditional manual screening. That study also showed no significant differences in trial eligibility and enrollment rates in separate analyses factoring in patients’ race, gender and ethnicity.
“Licensing RECTIFIER 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 RECTIFIER research co-senior author and AIwithCare CEO and co-founder Alexander “A.J.” Blood, MD, MSc, associate director of the Accelerator for Clinical Transformation and cardiologist in the Heart and Vascular Institute at Mass General Brigham.
“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,” added Sandy Aronson, president and Chief AI Officer, AIwithCare, former executive director of IT and AI at Mass General Brigham Personalized Medicine, and current digital research principal architect for the health system.
In addition to clinical trials, groups at Mass General Brigham are using RECTIFIER to accelerate patient identification and reduce the burden of manual chart review in clinical and population health use cases.
Pediatric gastroenterologists are using RECTIFIER to perform patient referral triage with demonstrated 94.7% accuracy, identifying urgent labs and symptoms buried within clinical notes with 98% accuracy. The Mass General Brigham Population Health Service Organization, a department responsible for improving care for over 650,000 patients through value-based models, has also used RECTIFIER to streamline patient assessment eligibility for a heart failure management program. Additionally, the group is using the tool to accurately identify those above their goal blood pressure, allowing health system resources to be directed towards them to reduce their cardiovascular risk. Other groups are using RECTIFIER to perform high-resolution phenotyping of patients with sickle cell disease or across ALS trials to accelerate patient identification and enrollment for faster access to potentially life-altering therapeutics.
Mass General Brigham Innovation, which facilitated the new company spinout, works with researchers throughout the healthcare system to manage tech transfer commercialization and coordinate industrial relationships such as licensing agreements, formation of new companies and other contracts, in addition to intellectual property (IP) management and general advising, with an ultimate goal of translating novel research advances and innovations from bench to bedside. In the past year alone, Mass General Brigham Innovation had more than 1,400 active licenses, more than 600 new inventions disclosed, and nearly 200 issued U.S. patents.
“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. “Deploying such technology more broadly could help reduce significant barriers in care delivery and ultimately accelerate clinical research.”
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About Mass General Brigham
Mass General Brigham is an integrated academic health care system, uniting great minds to solve the hardest problems in medicine for our communities and the world. Mass General Brigham connects a full continuum of care across a system of academic medical centers, community and specialty hospitals, a health insurance plan, physician networks, community health centers, home care, and long-term care services. Mass General Brigham is a nonprofit organization committed to patient care, research, teaching, and service to the community. In addition, Mass General Brigham is one of the nation’s leading biomedical research organizations with several Harvard Medical School teaching hospitals. For more information, please visit massgeneralbrigham.org.
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