Fierce Clinical Summit 2023
The Fierce Clinical Summit is the flagship event for clinical research and trial management professionals. The program covers a broad range of clinical research topics while also providing deep dives with tracks dedicated to the core facets of Clinical Development and Operations, GCP and Clinical Quality, and Decentralized Clinical Trials. Discover the latest trends, network with your peers, and learn about industry standards to foster strategic foresight and enable success in your clinical trials.
Session Information:
Title: Innovative Approaches to Collecting More Precise Patient Experience Data for Oncology Clinical Trials
Date: Wednesday, September 27, 2023
Time: 2:00pm – 2:30pm EST
Session takeaways:
- Review the background, history and evolution of PRO data collection in oncology trials, including the regulatory landscape
- Explore best practices and new/innovative methods for collecting what matters to the patient to inform regulatory decision making (i.e., new PRO assessment approaches, wearable devices)
- Discuss overcoming operational challenges, including adoption of accessible technologies, need for training, etc.
Speaker
Kelly Dumais, Ph.D.
Director, eCOA Science and Consulting 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 the Director of 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.
Panel title: Sustaining DCT Adoption in a Challenging Economic Environment
Date: Wednesday, September 27, 2023
Time: 2:30pm – 3:15pm EST
Panel takeaways:
Discuss challenges from the affordable care act on reimbursement and portfolio adjustments, biotech funding, site staffing, and the many other challenges making implementing new approaches in 2023.
Clario Panelist
Dr. Todd Rudo
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 Clario’s scientific resources to support customer success, Dr. Rudo has focused efforts on developing expertise across a range of therapeutic areas. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while also maintaining focus on patient and site burden. With nearly 20 years of clinical cardiology and pharmaceutical research experience, Dr. Rudo has focused predominantly on drug safety, working across a wide range of therapeutic areas.
Other Panelists:
- Jimmy Bechtel M.B.A. – Vice President, Site Engagement, Society for Clinical Research Sites (SCRS)
- Sandeep Bhat – Senior Leader, Digital Health Partnerships and Digital Engagement, Global Clinical Operations, GSK
Moderator: Craig Lipset, Clinical Innovation Partners, Advisor & Founder