Safety and Tolerability in Oncology Trials: Cardiac Imaging, ECG and the Role for Patient-Reported Outcomes

s clinical research in the oncology therapeutic area becomes increasingly complex, effectively capturing high-quality data across multiple endpoints becomes even more critical to a drug’s success. Many oncologic agents have cardiac toxicities, including depression of left ventricular function, QTc prolongation and elevation of blood pressure. Register for this webinar to learn about the intersection of oncology drug development and cardiac safety, and how this new area is changing the landscape for early-phase clinical trials. Cardio-oncology, an evolving subspecialty focused specifically on the detection and management of these risks, has become an essential consideration within any oncology development program. Additionally, with the growing emphasis on patient-focused drug development, recent regulatory guidelines now outline core patient-reported outcomes (PROs) that should be included in oncology clinical trials. Among these are self-reported symptomatic adverse events, with the new 2023 US Food and Drug Administration (FDA) draft guidance acknowledging the importance of utilizing this self-reported data to enhance the assessment of tolerability in early-phase dose optimization trials.

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