TY - JOUR T1 - Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data JF - Journal for ImmunoTherapy of Cancer JO - J Immunother Cancer DO - 10.1136/jitc-2021-002896 VL - 9 IS - 7 SP - e002896 AU - Kerry L Reynolds AU - Shaily Arora AU - Ravikumar Komandur Elayavilli AU - William C Louv AU - Teilo H Schaller AU - Aakanksha Khandelwal AU - Mace Rothenberg AU - Sean Khozin AU - Amanda C Guidon AU - Michael Dougan AU - Leyre Zubiri AU - Laura Petrillo AU - Meghan E Sise AU - Alexandra-Chloe Villani AU - Douglas B Johnson AU - Osama Rahma AU - Elad Sharon Y1 - 2021/07/01 UR - http://jitc.bmj.com/content/9/7/e002896.abstract N2 - Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, improving outcomes in patients with advanced malignancies. The use of ICIs in clinical practice, and the number of ICI clinical trials, are rapidly increasing. The use of ICIs in combination with other forms of cancer therapy, such as chemotherapy, radiotherapy, or targeted therapy, is also expanding. However, immune-related adverse events (irAEs) can be serious in up to a third of patients. Critical questions remain surrounding the characteristics and outcomes of irAEs, and how they may affect the overall risk–benefit relationship for combination therapies. This article proposes a framework for irAE classification and reporting, and identifies limitations in the capture and sharing of data on irAEs from current clinical trial and real-world data. We outline key gaps and suggestions for clinicians, clinical investigators, drug sponsors, patients, and other stakeholders to make these critical data more available to researchers for pooled analysis, to advance contemporary understanding of irAEs, and ultimately improve the efficacy of ICIs. ER -