Earlier this year, Clinical Leader featured an insightful article highlighting the innovative partnership between Takeda and Iterative Health to improve clinical trials for inflammatory bowel disease (IBD) using artificial intelligence (AI) and machine learning (ML). Dr. Vijay Yajnik, Vice President and Head of U.S. Medical Affairs at Takeda, shared how this collaboration leverages AI-driven endoscopic assessments to advance patient selection, clinical evaluation, and treatment pathways in IBD research. You can read the full article here.
The Challenge of IBD Clinical Trials
Inflammatory bowel disease clinical trials face significant hurdles in patient recruitment, disease severity assessment, and data accuracy. Traditional methods rely heavily on expert human reviewers to analyze endoscopic videos, which is both time-consuming and subject to variability. This human factor impacts the consistency of clinical trial data and can delay trial timelines, increasing costs for sponsors and limiting patient access to novel therapies.
Moreover, patient recruitment solutions are critical in IBD trials due to the complexity and heterogeneity of the disease. Clinical research sites struggle with enrolling the right patients, which slows clinical trial acceleration and impacts the overall success of studies.
How AI and Machine Learning Provide Solutions
By partnering with Takeda, Iterative Health is harnessing clinical research technology to transform the assessment and execution of IBD clinical trials. Leveraging machine learning algorithms, Iterative Health processes large volumes of de-identified endoscopic videos and electronic health records from over 100 GI community sites across seven states. These AI-powered models provide objective, reproducible scoring of disease severity in patients with ulcerative colitis.
This approach enhances trial data accuracy by reducing human bias and variability, enabling sponsors and clinical research teams to make more informed decisions. AI in clinical trials also streamlines patient recruitment by facilitating efficient identification and selection of eligible participants, ultimately accelerating trial timelines.
Transforming Clinical Trial Design and Execution
The integration of AI and machine learning into clinical trials improves patient screening, study design, and operational efficiency. Iterative Health’s technology offers clinical site optimization by enabling precise, data-driven insights into disease progression and treatment response. This leads to better alignment of trial protocols with real-world clinical practice and supports sponsors in meeting enrollment goals more rapidly.
These advancements contribute to clinical trial acceleration by reducing delays and minimizing costly protocol amendments. By incorporating AI-based patient recruitment solutions and scalable disease assessments, research sponsors can enhance trial quality while controlling expenses.
Broader Impact for Sponsors, Sites, and Patients
Dr. Yajnik highlights that this AI collaboration is already shaping Takeda’s drug development and post-market strategies. Sponsors benefit from increased confidence in clinical trial outcomes due to more reliable data and efficient trial execution. Clinical research sites experience reduced administrative burden and improved workflow efficiency, fostering higher trial throughput.
Most importantly, patients gain earlier access to innovative treatments informed by objective, high-quality clinical trial evidence. As AI technology continues to evolve, its integration promises to further accelerate clinical trial timelines and improve therapeutic development.
About Iterative Health
Iterative Health is a leader in healthcare technology, dedicated to accelerating clinical trials and enhancing patient outcomes through innovative AI-powered solutions. Our expertise spans gastroenterology clinical trials, clinical site optimization, and advanced machine learning applications in clinical research. We partner with sponsors, research sites, and healthcare providers to expand patient access to breakthrough therapies and drive faster, more accurate trial results.
Ready to accelerate your clinical trials with advanced AI and machine learning technology?
Contact Iterative Health today to learn how our cutting-edge clinical research technology can optimize your clinical trial processes and improve patient recruitment efficiency.
About Iterative Health
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Today, Iterative Health is based in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.
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