Overview
Cancer treatments are becoming more effective but also more complex. For patients, tolerability is about more than side effects listed in a clinical trial report. It’s about how treatment impacts daily life, comfort, and the ability to keep going.
DIA has launched the first phase (Phase I) of a study to create the first standardized, patient-centered definition of treatment tolerability with a focus in immuno-oncology treatments. Working with experts from leading biopharmaceutical companies, research institutions, and patient advocacy groups, we are capturing perspectives from both the clinic and the real world to ensure tolerability is understood—and measured—in ways that truly matter to patients.
Why It Matters
Today, there’s no common definition of “tolerability” in immuno-oncology. Regulators and trial designs often rely on clinician-reported side effects and treatment discontinuation rates, metrics that miss critical aspects of a patient’s lived experience.
We're filling that gap by:
- Creating a standard definition that incorporates both clinical and patient-reported data.
- Elevating the patient voice to reflect how people feel, function, and cope during treatment.
- Driving practical change in how tolerability is assessed, reported, and acted upon in future trials.
Impact & Outputs
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Conferences
At the DIA 2025 Global Annual Meeting (Washington, D.C.) and DIA Europe 2025 (Basel), we shared our methodology and early findings, sparking important conversations on integrating patient experience into regulatory science and trial design.
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Publications
In Global Forum (April 2023): we published “Immunotherapies Merit Unique Patient‑Reported Outcomes to Inform Treatment Tolerability”. Co-created with study partners and subject matter experts, the article laid out the case for new, custom-designed PRO measures and invited open collaboration from the oncology community. This early publication set the tone for transparency and collaboration, shaping the study’s vision from the start.
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Join the conversation
By sharing evidence and inviting diverse perspectives, we’re building a foundation that will shape how cancer treatment tolerability is understood worldwide. Join us in shaping the future of patient-centered cancer care.
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If you or your organization want to learn more about DIA’s Research projects or Think Tanks please contact Science@DIAglobal.org.