Integrating Objectively Measured Safety Endpoints and Patient-Reported Outcomes in Oncology Trials: A Scientific Approach Webinar Replay
Part 3 of the Clario Oncology Webinar Series
In the ever-evolving landscape of drug development within oncology, the importance of collecting high-quality data across multiple endpoints cannot be overstated. This data plays a pivotal role in determining the success of a drug. The integration of objective safety measurements with patient-reported outcomes is now essential in characterizing a drug’s safety profile, influencing overall benefit-risk considerations. Clario invites you to explore our comprehensive scientific approach to enhancing safety and tolerability assessments in oncology trials through this webinar.
Oncologic agents frequently exhibit cardiac toxicities, including left ventricular function depression, QTc prolongation, and blood pressure elevation. This has given rise to the emerging field of cardio-oncology, dedicated to detecting and managing these risks within oncology development programs. Furthermore, as the focus on patient-centered drug development grows, recent regulatory guidelines now outline core patient-reported outcomes (PROs) to be incorporated into oncology clinical trials. Among these are self-reported symptomatic adverse events, with the 2023 draft FDA guidance emphasizing their importance in enhancing tolerability assessments, particularly in early-phase dose optimization trials.
Technological advancements in wearable sensor technology have introduced cutting-edge sensors and analytics capable of monitoring and analyzing patient mobility and activity levels during oncology trials. This proactive approach facilitates the early detection of safety concerns, further enhancing patient safety and data integrity.
In Part 3 of the Clario Oncology Webinar Series replay, expand your knowledge and contribute to the advancement of patient safety and data quality within the field of oncology research.
What you’ll learn:
- Introduction to cardio-oncology as a subspecialty, understanding the unique aspects of assessing cardiac safety within an oncology development program.
- Improve awareness of ECG best practices for assessment to detect drug-induced QT prolongation, the role for BP monitoring in oncology studies, and cardiac imaging to detect changes in cardiac function.
- The importance of integrating objective safety measurements with patient-reported outcomes to comprehensively assess a drug’s safety profile in oncology trials.
- The use of wearable sensor technology to proactively monitor patient mobility and activity levels, enabling early detection of safety concerns and enhancing overall data integrity in oncology trials.