Using Scientific Validation to Move the Needle on Accessibility Functionalities
Part 2 of the Clario Oncology Webinar Series
Start time: 11am EST (NA) / 4pm GMT (UK) / 5pm CET (EU-Central)
Session information:
With the advance of technology, new opportunities to improve clinical trial experience from a site and patient perspective come into existence. As regulatory bodies are demanding use of accessibility functionality to improve inclusivity, Clario’s scientific team is currently assessing the level of scientific research required to validate the use of the accessibility features such as zoom in/zoom out and ensure data integrity is maintained.
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.
What you’ll learn:
- All eCOA equivalence studies that have been carried out in the last 20 years before have paved the way for accessibility functionality testing.
- Accessibility features require science to assess if there could be a potential impact on data integrity.
- Although initial research has been completed, there is further work to be done to make accessibility a reality for would-be trial participants.
Moderator
Bryan McDowell, M.Sc., M.B.A.
Vice President eCOA Clinical Science and Consulting at Clario
In his role as VP, eCOA Science and Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma-wide industry necessity for smarter drug & device development and life cycle management.
Speakers
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.
Sarah Gary, M.S., Ph.D.
Senior Scientific Advisor at Clario
Dr. Tressel Gary has over five years of experience in clinical trial design and strategy, and more than two years of experience in ePRO and the development and validation of PROs in support of labeling claims. She has significant experience working with PRO development and validation studies, questionnaire design and working with developers of standardized instruments. She is experienced in migration studies including cognitive debriefing and usability testing in a number of therapeutic areas. Her clinical research experience was focused on hemostasis/ thrombosis, platelet biology, oncology, angiogenesis, atherosclerosis and cardiovascular disease. She has extensive in vivo and in vitro lab experience and has conducted preclinical studies in support of trials. To date, Dr. Tressel Gary has co-authored 12 publications and received several honors and awards, including an AHA Postdoctoral Fellowship.
Joe Pavone
Program Lead, Digital Health Technologies Operations at Regeneron
Joe is the Program Lead of Digital Health Technologies Operations at Regeneron, where he manages and supports local and global clinical trial services and study management teams. Joe has 25+ years of pharmaceutical industry experience, having had roles as global ePRO project manager and program lead for eCOA operations in numerous premier pharmaceutical companies.
Check out the rest of the Clario Oncology Webinar Series
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Webinar Event
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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Integrating Objectively Measured Safety Endpoints and Patient-Reported Outcomes in Oncology Trials: A Scientific Approach
This webinar explores a comprehensive approach to enhance safety and tolerability assessments in oncology research and will expand your knowledge and contribution to the advancement of patient safety and data quality.
December 13, 2023