DIA, a global non-profit organization of life sciences professionals, has launched a research study in collaboration with leading global biopharmaceutical companies AbbVie and Sanofi that aims to establish a standard definition of tolerability in cancer treatment. This study seeks to understand patients' tolerance to treatment by examining their experiences with immuno-oncology drugs and use that information to inform clinical trial design and benefit-risk assessments.

The lack of a standardized definition of tolerability limits pharmaceutical companies and regulators in shaping clinical trials and evaluating new cancer treatments, especially those with complex side effects. Tolerability assessments in regulatory submissions often rely heavily on adverse event reporting by clinicians and discontinuation rates. Likewise, while clinical measures such as tumor response and survival rates are essential, there is growing recognition that patient-reported outcomes offer equally valuable insights. This study intends to determine more precise guidelines, informed directly by patient experiences, to better support drug development and regulatory decision-making.

"Patients are the ones who live with the effects of these treatments firsthand, yet their voices are rarely heard during the drug development and clinical research processes," said Radha Goolabsingh, Global Regulatory Strategy and Engagement Leader for DIA. "By understanding patients’ experiences and tolerance levels, we can design clinical trials that better reflect real-world treatment conditions and create immunotherapy treatments that balance therapeutic impact with quality of life."

Experiences with cancer treatments vary significantly based on multiple factors, including a patient's stage of disease, previous therapies, overall health status, and personal circumstances. What is tolerable to one patient might be intolerable to another, particularly when factoring in quality of life, family obligations, or ability to work. This complexity underscores the importance of gathering diverse patient perspectives to inform treatment decision-making.

The study will enroll 40 patients in the United States who are receiving personalized treatments for various forms of cancer, including solid tumors such as lung and colorectal cancers, as well as liquid tumors like multiple myeloma and acute myeloid leukemia. These participants will share which aspects of their treatments they find tolerable or intolerable through a structured online platform that allows them to contribute their insights while accommodating their health needs and treatment schedules.

ICON will serve as the study's research vendor. The Critical Path Institute, Friends of Cancer Research, the University of Birmingham's Centre for Patient Reported Outcomes Research, the LUNGevity Foundation, and Myeloma Patients Europe (MPE) will form the advisory group.

Dr. Catherine Coulouvrat, Head of Health Value Translation at Sanofi, conceived this project, and her contributions are fundamental to its existence. Rohini Sen, Ph.D., M.S., Director of Patient Centered Outcomes Research (PCOR) Oncology HEOR at AbbVie, has also provided significant assistance throughout this project's conception.

Organizations interested in joining this collaborative research initiative, or patients who wish to participate in the study, can contact radha.goolabsingh@diaglobal.org.