Integrating Objectively Measured Safety Endpoints and Patient-Reported Outcomes in Oncology Trials: A Scientific Approach
Part 3 of the Clario Oncology Webinar Series
Start time: 10am EST (NA) / 3pm GMT (UK) / 4pm CET (EU-Central)
Session information:
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.
Join us in expanding your knowledge and contributing 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.
Speakers
Todd Rudo, M.D.
EVP and 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 our scientific expertise to support our customers’ success, Dr. Rudo has focused efforts on optimizing our solutions across the therapeutic areas. His team supports Clario’s clients by providing expert consulting services on scientific and regulatory strategy, and ensures our 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 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.
Vic Patel, M.D.
Vice President and Chief Medical Officer, Cardiology at Clario
Vic Patel, M.D., Ph.D., is board certified in cardiology with a Ph.D. in Biophysics and done extensive research on mechanisms of cardiac arrhythmias. He was on faculty at U. Penn. School Medicine for 11 years where he directed Molecular Arrhythmia Research and practiced clinical electrophysiology. Dr. Patel then moved into drug development and cardiac safety as a clinical development leader and therapy area head across all phases.
At Clario, Dr. Patel oversees cardiology consulting and ECG/Holter core lab services, while leading the biostatistics and medical writing groups. He works with our global customers to ensure they are satisfied and provided with robust, cost-effective solutions.
Kelly Dumais, Ph.D.
Director, eCOA Science and Consulting at Clario
Dr. 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 the Director for eCOA Science and Consulting 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.
Adam Jagodinksy, Ph.D.
Scientific Advisor, Precision Motion at Clario
Dr. Jagodinsky is a scientific advisor and oncology lead on the Precision Motion Science and Consulting team where he works to advance the use of digital health technologies in clinical and academic research. Dr. Jagodinsky consults with sponsors on implementing wearable sensor solutions in clinical trials and provides comprehensive scientific support surrounding instrumented test and endpoint selection. Prior to joining Clario, Dr. Jagodinsky earned tenure in the Department of Exercise Science at Illinois State University. He has a background in biomechanics and human movement science, and his research focuses on the mechanics and control of gait and posture as well as leveraging technology for field-based human movement assessment.
Tonya Varcelli, Ph.D.
Director, Medical and Scientific Affairs, Cardiovascular Imaging (CVI) at Clario
Tonya has 20+ years’ experience as a subject matter expert supporting clients to ensure comprehensive delivery of services for clinical trials. In her current role, she provides medical and scientific support to sponsors for study-specific imaging acquisition and tailored assessments, as well as to Cario study teams to identify new tools and services that improve and expand Cardiovascular Imaging services. She was previously an Imaging Research Scientist responsible for research and development of scientific imaging-related documentation for 80+ clinical trials; including Phase II-IV, and pilot studies involving medical devices, pharmaceuticals, and combination products (biologics). Tonya began her career as a Ph.D. candidate at the Cleveland Clinic, followed by a role as a Clinical Trial Manager focusing on imaging components within Phase II-IV trials. She received her Ph.D. in Biomedical Engineering from Case Western Reserve University where she also earned her Master of Science and Bachelor of Engineering, Summa Cum Laude.
Check out the rest of the Clario Oncology Webinar Series
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Revolutionizing Oncology Clinical Trials: The Transformative Power and Promise of AI-Enhanced Medical Imaging
This webinar explores current advancements in AI that enhance the efficiency of oncology clinical trials, focusing on medical imaging and the potential that deep learning and generative AI hold in this dynamic field.
November 28, 2023
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Using Scientific Validation to Move the Needle on Accessibility Functionalities
In the webinar, the presenters will discuss the accessibility features and present results to date on this industry first study and provide an insight into the next steps for accessibility functionalities.
December 4, 2023