Sensor-Enhanced eCOA

Through structured collaboration, members will align on clinical, commercial, and regulatory needs and success criteria for CRS monitoring products, including:

• Interviews with patients, clinicians, and investigators to define user needs, workflow fit, and usability criteria
• Workshops with payors, regulators, and health systems to evaluate utility, reimbursement, and adoption
• Best practices for objective CRS grading, adverse event adjudication, and precise data collection guidelines
• Standardized protocols and tools needed for widespread community clinic adoption. This standardization requires a consensus amongst experts in how adverse events are defined.

Collaboration from the first workstream will inform the largest prospective study of its kind focused on developing scalable solutions to increase immunotherapy access in community settings, which will be carried out as part of workstream 2.

Collect a high-quality dataset with approved immunotherapies to develop a CRS early warning model with this effort informed by workstream 1.

• Prospective study with at least 150 patients on approved CAR-T and TCE immunotherapies to build a robust real-world dataset
• Model development and validation for early CRS detection. Analysis of model generalizability across modalities and future sample size requirements for different intended uses
• Care providers need guidance and alerting tools to aid in the standardization of adverse event management. This guidance and these tools are data-driven products that require this unique, first-in-kind data gathering effort.