Cytokine release syndrome (CRS) is a serious, potentially life-threatening adverse event associated with certain immunotherapies, particularly CAR T-cell therapy. Early detection of CRS is critical for timely intervention and improved patient outcomes. Digital measures, such as wearable sensors monitoring physiological signals in the real world, offer the potential for continuous, remote monitoring of patients at risk of developing CRS. However, the development and validation of these measures require a collaborative effort to establish a common ontology, prediction/monitoring model, and technical standards for data collection and analysis.

 

The Digital Medicine Society (DiME) has initiated work to define the ontology for digital measures of CRS. This project aims to build upon this foundation by seeking alignment on the CRS prediction/monitoring model and technical standards for wearable devices.

 

Overall Goal:

Review and Synthesize: Conduct a comprehensive review of publicly available information on digital measures for early detection of CRS in real-world settings using wearable sensors.

Model Alignment: Develop a consensus-based CRS prediction/monitoring model that incorporates relevant digital biomarkers and clinical parameters.

Technical Standards: Define technical standards for wearable sensor modalities to ensure data comparability across different devices and studies.

 

Specific Objectives:

Identify and evaluate existing digital measures for CRS detection, focusing on those utilizing wearable sensors.

Analyze the sensitivity, specificity, and predictive value of different digital biomarkers for CRS onset and severity.

Develop a standardized data collection protocol for wearable sensors in CRS monitoring.

Establish guidelines for data analysis and interpretation to ensure consistent and accurate results.

Collaborate with stakeholders to refine and validate the CRS prediction/monitoring model.

 

Potential Benefits:

Early detection of CRS, leading to timely intervention and improved patient outcomes

Enhanced safety monitoring of immunotherapies

Acceleration of digital measure development and regulatory acceptance

Improved understanding of the physiological changes associated with CRS

Facilitation of comparative effectiveness research and data sharing across studies

 

Call for Collaboration:

This initiative aims to unite stakeholders involved in the development and deployment of immunotherapies, including:

Pharmaceutical companies with oncology products/pipelines

Wearable sensor manufacturers

Academic researchers

Regulatory agencies

Patient advocacy groups

By leveraging the expertise and resources of diverse stakeholders, we can accelerate the development of validated digital measures for early CRS detection, ultimately improving patient care and safety.

 

Ways of contributing to a DEEP collaboration mission:

There are many ways that you can contribute to a DEEP collaboration mission. Contributions can be in the form of funding, time & expertise or prior work you have completed and would like to contribute to the cause in exchange for others contributions. DEEP's built in legal framework and mission contracting services aim to simplify the process of collaboration for all partners who would like to engage.

 

If you have questions, or if your organization is interested in contributing, please reach out to us here: