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In support of the need for more advanced Digital Health Technologies, ACCC partnered with DiMe to create comprehensive resources that support the development of trustworthy CRS de-risking products.
Throughout the care continuum, cancer treatment undeniably takes a toll on patients and their caregivers from the moment the weight of a diagnosis settles on their shoulders and well into survivorship care. Time and time again, patients express the burden of inpatient care and the desire to be at home with their support system as much as possible.
For patients with cancer receiving immunotherapies, a significant concern and threat to that ability to remain at home is Cytokine Release Syndrome (CRS). Often a side effect of immunotherapy, CRS is a condition that develops when an individual's immune system responds too aggressively to infection, causing the body to release cytokines and often manifesting in the form of fever and fatigue. If not detected quickly and closely monitored, CRS presents a risk to patients’ lives, and therefore requires regular clinical oversight through extended hospitalizations.
In response, many providers and developers have turned to digital health technologies (DHTs) during treatment, which have matured to the point that they can more quickly detect CRS and mitigate the risks it poses. The use of DHTs also enables monitoring and risk prediction beyond the clinic, enabling patients to spend less time in inpatient settings and reduce the burden on health care systems.
In support of this growing shift and the need for more datasets to develop more advanced DHTs, the Association of Cancer Care Centers (ACCC) partnered with the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) to create comprehensive resources that support the development of trustworthy CRS de-risking products. In turn, ACCC and DiMe aim to improve patient safety and outcomes on a global scale and shape the future of cancer care by making immunotherapies safer, more accessible, and more equitable.
First in the package of resources is a detailed guide aimed at developers, complete with actionable recommendations for developing CRS de-risking products and milestones for bringing a safe and effective product to market. Other resources include infographics of digital clinical measures that provide insight into CRS onset and progression, and an innovation roadmap that lays out key milestones to inform the development of a CRS de-risking product.
To introduce these resources and their positive impact, DiMe hosted a launch webinar in February 2025 during which a variety of patient organizations, clinicians, biopharmaceutical companies, and DHT companies were represented. The group discussed how the resources born out of this partnership create a strategic path to develop reliable and scalable CRS de-risking products, as well as how these products can improve patient safety, clinical outcomes, and access to life-saving therapies.
Michael Hibberts, a patient diagnosed with multiple myeloma, shared insights from his 10-year journey with the disease and his treatment with chimeric antigen receptor (CAR) T-cell therapy. He highlighted how at-home monitoring provided both safety and comfort during treatment, and the importance of reliable remote monitoring and clear communication of symptoms. “The equipment I had at home allowed nurses to monitor me 24 hours a day, so I did receive phone calls in the middle of the night about my fever, explaining to me how important it was [to relay my side effects].”
From a clinical perspective, remote monitoring fills a critical gap. Clinicians discussed difficulties in identifying early signs of CRS, especially outside of inpatient settings. Traditionally, patients who receive CAR T-cell therapy are monitored in an inpatient setting with their vitals taken every 4-6 hours. However, in the absence of a 24-hour monitoring system, the subtle changes in temperature and heart rate that precede a CRS episode may be missed in the interim between these checks. Early detection through remote monitoring could allow patients to stay safely at home, reduce financial burden, and prompt timely intervention.
As more and more immunotherapies come to market and case loads expand, it’s also important to acknowledge the role a CRS risk prediction plays—particularly in considering which patients are eligible for remote patient monitoring. This highlights a crucial equity concern, as patients with lower health literacy or less caregiver support are at greater risk of delayed care and worse outcomes.
For digital solutions to be effective, they must meet real-world patient needs. That means DHTs must be noninvasive, easy to use, and comfortable to wear, to ensure maximum patient compliance. These devices must also be capable of capturing interpersonal variation from the baseline, as every patient is going to differ in what is typical for vitals like temperature and heart rate. When clinicians see deviations from that baseline, they will then have a better understanding of the level of risk for CRS.
Diversity in clinical trials is particularly key in the development of DHTs. By nature, CRS can cause significantly different side effects across patient populations, due to differences in how the immune system responds to therapies and differences in comorbidities. Having a diverse patient population therefore helps to ensure that the de-risking product can work across different demographics.
A successful path to market requires thoughtful collaboration with regulators. Developers must carefully craft their pitch before engaging with regulators, making sure they have considered how much risk is involved in using the product, whether there are journal articles that substantiate the chosen parameters, and whether key opinion leaders and other standards of care have been consulted. In addition, developers must consider not just how their product works, but its impacts on downstream treatment and how it fits into the overall CRS risk management ecosystem.
Long-term engagement with regulators throughout the phases of design is also essential. Clear communication in early engagements builds the foundation for smoother collaboration through every phase of development. One expert noted that thinking of regulators as collaborators, rather than adversaries, can be an effective mindset. “We all want the same thing. The regulators are just trying to do the best for patients and the clinicians caring for them,” he explained. “Our focus should always be on the patient journey.”
While regulatory collaboration and digital innovations are paving the way for safer, more efficient cancer treatments, the most powerful reminder of their importance often comes from the patients themselves.
A representative from DiMe gave final remarks about her recent diagnosis with stage III colon cancer and spending 27 days in the hospital. Her experience gave her a renewed appreciation for the importance of the work her organization is doing, emphatically stating that she would have done anything if it meant going home just 1 day earlier to her support system. This perspective brings into focus the real-world impact of DHTs on patients with cancer and the importance of this continued work.
Partners for this Education Project 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, and the National Cancer Institute/National Health Institute.
Find more related content on the ACCC OPTIC Provider Education Program page.
