In this free webinar, learn about the unique aspects of assessing cardiac safety within an oncology development program. The featured speakers will discuss ECG best practices for assessment to detect drug-induced QT prolongation. Attendees will learn about the role of blood pressure monitoring in oncology studies and cardiac imaging to detect changes in cardiac function. The speakers will discuss how patient-reported outcomes (PROs) for oncology clinical trials can help inform not only the risk but also the benefits seen by patients. Attendees will learn how PROs can aid in complying with the new 2023 draft FDA guidance.
TORONTO, March 20, 2023 /PRNewswire-PRWeb/ -- As 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Among these are self-reported symptomatic adverse events, with the new 2023 US Food and Drug Administration (FDA) draft guidance acknowledging the importance of utilizing this self-reported data to enhance the assessment of tolerability in early-phase dose optimization trials.
To accommodate the recommendations for enhanced detection strategies, the featured speakers will discuss key topics, including: Feasibility and best practices for PRO collection; Technologies for ECG collection; Blood pressure monitoring and cardiac imaging; And enhancing data quality without substantially increasing patient burden.
The integration of objectively measured safety endpoints with PROs is essential in characterizing the safety profile of a drug, which ultimately informs the overall benefit-risk considerations for the program.
Join this webinar for an introduction to cardio-oncology and ECG best practices, as well as a discussion of the benefits of PROs.
Join experts from Clario, Todd Rudo, MD, EVP & Chief Medical Officer; Robert Kleiman, MD, Vice President & Chief Medical Officer, Cardiology; Mori Krantz, MD, Senior Cardiologist, Chief Science Advisor, Cardiac Safety & Cardiovascular Imaging; and Kelly Dumais, PhD, Principal Scientific Advisor, for the live webinar on Tuesday, April 11, 2023, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Safety and Tolerability in Oncology Trials: Cardiac Imaging, ECG and the Role for Patient-Reported Outcomes.
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Contact:
Vera Kovacevic
Tel: +1 (416) 977-6555 x371
Email: [email protected]
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Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, [email protected]
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