MUMBAI, India, Sept. 7 -- Intellectual Property India has published a patent application (202641104108 A) filed by Dayananda Sagar College Of Engineering on August 29, 2026, for System And Method For Clinical Trial Patient Monitoring And Device-Triggered Cohort Reassignment.
Inventors include Ayush Kumar; Aishwarya Kumari; Dr. D. R. Ramesh Babu; and Shefali Ganapathy.
The application for the patent was published on September 04, 2026, under issue no. 36/2026.
Abstract: This invention discloses a closed-loop system that automatically re-optimizes clinical trial cohort assignments in direct response to sustained physiological deviation detected in enrolled patients, without human initiation. A wearable sensor continuously reports physiological parameters, including SpO2 and heart rate, for each enrolled patient. A deviation-detection unit compares incoming readings against a per-patient baseline and classifies sustained deviations into severity tiers. Upon a qualifying tier, the system automatically updates the affected patient's survival/dropout risk weight and automatically triggers partial re-solution of a combinatorial cohort-assignment optimization problem, restricted to the sub-cohort affected by the deviation, without clinician-initiated review and without re-solving the full cohort. The re-optimization problem is formulated as a Quadratic Unconstrained Binary Optimization (QUBO) objective and solved via a hybrid quantum/classical process. Restricting re-solution to the affected sub-cohort reduces the number of binary decision variables processed relative to a full-cohort re-solve, reducing the computation time and resources required. Supporting modules a Domain-Specific Language (DSL) protocol compiler, a federated multi-site data layer, and an automated compliance-report generator provide the constraint inputs, multi-site scalability, and audit output that the closed-loop trigger operates upon, but the inventive core is the autonomous, sensor-driven, partial-cohort re-optimization action itself.
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