Safety and Tolerability in Oncology Trials: Cardiac Imaging, ECG and the Role for Patient-Reported Outcomes
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Among these are self-reported symptomatic adverse events, with the new 2023 US Food and Drug Administration (FDA) draft guidance acknowledging the importance of utilizing this self-reported data to enhance the assessment of tolerability in early-phase dose optimization trials.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
- 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.
Session Information:
Join this webinar for an introduction to cardio-oncology and ECG best practices, as well as a discussion of the benefits of PROs.
Who should attend?
- Clinical Pharmacologists
- Clinical Operations (Early Phase)
- TA Experts (Oncology)
- Medical Monitor/Head of Development for Program
- Clinical Operations
- Clinical Development
- Clinical Research
- Regulatory Affairs
- Clinical Monitoring
- Clinical Scientists
- Imaging Scientists
- Protocol Managers
- Clinical Data Managers
What you will learn
- Cardio-oncology as a subspecialty
- The unique aspects of assessing cardiac safety within an oncology development program
- Improving awareness of ECG best practices for assessment to detect drug-induced QT prolongation
- The role for BP monitoring in oncology studies
- Cardiac imaging to detect changes in cardiac function
- How PROs for oncology clinical trials can help inform not only the risk but also the benefits seen by patients
- How PROs can aid in complying with the new 2023 draft FDA guidance
Speakers
Todd Rudo, M.D.
EVP & Chief Medical Officer at Clario
As Clario’s Chief Medical Officer, Dr. Todd Rudo provides medical and scientific leadership across the organization. Passionate about leveraging their scientific expertise to support their customers’ success, Dr. Rudo has focused efforts on optimizing their solutions across the therapeutic areas. His team supports Clario’s clients by providing expert consulting services on scientific and regulatory strategy, and ensures their product portfolio is scientifically robust, generating high-quality data to support clinical trial endpoints. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.
With nearly 20 years of clinical cardiology and pharmaceutical research experience, Dr. Rudo has focused his career predominantly on drug safety. He has worked within various therapeutic areas, including oncology, immuno-inflammatory diseases, urology and cardiometabolic diseases, and has achieved board certifications in internal medicine, cardiology, cardiac electrophysiology, nuclear cardiology and adult echocardiography.
Robert Kleiman, M.D.
Vice President & Chief Medical Officer, Cardiology at Clario
Dr. Robert Kleiman is the VP & Chief Medical Officer for Cardiology at Clario, with board certifications in cardiology and cardiac electrophysiology. He has performed research in both basic cellular electrophysiology as well as clinical electrophysiology. Dr. Kleiman trained at the University of Pennsylvania and practiced clinical cardiology for 12 years before joining Clario in 2003.
In his current role, he currently oversees all of Clario’s cardiology services, supports business development and provides cardiac safety consultative services advising sponsors on optimal cardiac safety strategy for their development program (e.g. clinical protocol development, expert cardiac report development and regulatory support).
Mori Krantz, M.D.
Senior Cardiologist, Chief Science Advisor Cardiac Safety & Cardiovascular Imaging at Clario
Dr. Mori Krantz is a Senior Cardiologist & Chief Science Advisor, Cardiac Safety and Cardiovascular Imaging at Clario, with board certifications in cardiology and is certified (level III) by the National Board of Echocardiography. Dr Krantz trained at the University of Colorado. He has had a long-standing interest in QT-liability and cardiac safety. He served as a permanent member of the FDA Cardiac & Renal Drugs Advisory Committee after discovering an association between opioids and torsade de pointes. He is the current governor of the Colorado chapter of the American College of Cardiology and serves on the Board of Trustees for the International Society of Holter and Non-Invasive Electrocardiography.
In his current role, he supports business development and provides cardiac safety consultative services advising sponsors on optimal cardiac safety strategy for their development program (e.g. clinical protocol development and regulatory support). He also provides consultative services for the design of clinical trials that require cardiovascular imaging for both safety and efficacy endpoints.
Kelly Dumais, Ph.D.
Principal Scientific Advisor at Clario
Dr. Kelly Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is currently a Principal Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.