Collaborative Care: Implementing an Innovative Digital Tool

The Association of Cancer Care Centers (ACCC) recently announced a collaboration with the Digital Medicine Society (DiME) on a project focused on leveraging digital innovations to support the development of a risk prediction tool for cytokine release syndrome (CRS).

The Digital Health Measurement Collaborative Community by DiME is a collaborative initiative with the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. This community provides a forum for collaboration where partners and experts from across the digital health care field can convene to advance the use of digital health tools in research to improve the lives of patients with certain types of cancers.

The advancement of digital technologies has facilitated the development of tools that can be used to predict the onset of CRS outside standard health care settings (eg, comprehensive cancer centers, etc). Consequently, CRS has become a significant risk factor of interest to pharmaceutical/biotechnology companies, hospital systems, payers, regulators, and, most importantly, patients.

Background

An overview of the current oncology landscape reveals that some of the most exciting therapeutic developments coming into clinical practice are novel T-cell redirecting immunotherapies for treating hematological cancers like leukemias, lymphomas, and multiple myeloma. This is especially true for patients that have exhausted other treatment options. Two examples of these immunotherapies are chimeric antigen receptor (CAR) T-cell and bispecific T-cell engagers (BiTEs).

Although these therapies offer targeted, better-tolerated treatment options with promising results—such as new hope for improved survival rates and enhanced quality of life—the clinical adoption of these novel therapies has been plagued by serious adverse events, for example, high-grade CRS.

Also known as cytokine storm, CRS is a systemic inflammatory response that is caused by a large, rapid release of cytokines (eg, IL6, TNFα, IL8, etc) into the blood by immune cells in response to T-cell redirecting immunotherapies. This pro-inflammatory response is a complex constellation of low-grade adverse effects (eg, fevers and rashes) to high-grade, life-threatening adverse effects (eg cardiac arrest, multi-organ failure or even death) which occur if the onset of CRS is not closely monitored and properly managed.

If detected early, the symptoms of CRS are treatable. Thus, identifying the onset of the syndrome in patients undergoing a particular type of T-cell redirecting immunotherapeutic treatment is critically important to enable the hematologist/oncologist to make appropriate adaptive decisions that optimize patient safety.

High-grade CRS has posed tremendous difficulties for patients in both clinical trials and practice since the adoption of T-cell redirecting immunotherapies. Despite the favorable impacts these novel therapies have had on the treatment of patients with hematologic cancers, their administration has been limited to large comprehensive cancer centers with the requisite specialized staff and facilities. Further, patients must travel to these comprehensive cancer care centers to receive treatment. Following treatment, patients must remain at the hospital for careful observation and monitoring for any potential adverse effects for several days. This process is inconvenient for the patients who have access to this care. Although there are many who face access challenges due to the high costs of these novel therapies.

Leveraging Digital Tools

The goal of the Advancing Digital Capabilities to Enable Digital Risk Prediction for CRS is to provide hematology/oncology specialists and researchers with the resources to identify, treat, and manage CRS in patients with cancer using digital tools. These resources aim to reduce patients' time spent in inpatient healthcare settings, alleviating additional risks and stressors amidst their already challenging cancer experiences. This work will pave the way for reduced costs and increased access to immunotherapies, and drive the development of high-quality, trustworthy tools that can save lives.

Key Project Priorities

The project will produce publicly available resources to interested parties across the cancer care continuum to drive the development, adoption, and scaling of novel digital technologies to redefine the delivery of health care and improve the lives of patients.

To accomplish critical milestones for the project, collaborators will:

• Define common technical parameters, an ontology, and a data model for the digital measurement of CRS.
• Explore regulatory considerations and evidentiary requirements for the digital tool.
• Establish what good technical performance looks like.
• Define operational best practices to support the development and implementation of digital capabilities in a risk prediction tool for CRS across multiple care settings.

Project Workstreams

• Workstream 1: Measure development and ontologies/ontological toolkit.
• Workstream 2: Development of a model assessment tool to support organizations and identification of the right regulatory pathways.
• Workstream 3: Conduct industry briefs to ensure that users/adopters are set up for success via training to properly operate the digital risk prediction of the CRS toolkits.
• Workstream 4: Provide operational best practices of the digital toolkits. 

Looking Foward

ACCC is also pleased to collaborate with DiME and other partners involved in this project through CancerX, the digital innovation-focused public-private partnership under the White House’s Cancer Moonshot Initiative. You can learn more about CancerX here.

Additional Resources

• Tips for Early Patient Identification for CAR T-Cell Therapy and Care Continuity with Community Providers
• ACCC Immuno-Oncology Institute
• Oncology Practice Transformation and Integration Center
• Leveraging Digital Innovations to Support the Development of a Risk Prediction Tool for CRS

Project partners include: ACCC, Actigraph, Atrium Health - Levine Cancer Institute, ASH Research Collaborative, Best Buy Health, Biofourmis, Blue Spark Technologies, Bristol Meyers Squibb, Doccla, FDA, Foundation for the National Institutes of Health, Friends of Cancer Research, Genentech and Roche, IEEE, J&J Innovative Medicine, Leukemia & Lymphoma Society, Mika Health, Orion Pharma, Pfizer, Takeda, Verily, National Cancer Institute/National Health Institute.