This webinar explores cutting-edge strategies in ophthalmology clinical trials focused on improving patient access and precision analysis with supplemental artificial intelligence (AI) support. Attendees will gain insights into innovative approaches that can be applied across numerous trial settings.
Beginning with a comprehensive overview of the requirements in ophthalmology clinical trials, the webinar discusses the need for vendor-agnostic, multi-modality platforms in trial design. Inclusion of a browser/cloud-based system ensures regulatory compliance and transparency while offering AI-enabled workflow design for real-time analysis and reporting.
Highlighted case studies demonstrate AI’s transformative impact, particularly in conditions such as dry age-related macular degeneration (AMD). By augmenting traditional metrics with AI-generated analysis, connections to functional improvement and drug efficacy are enhanced, streamlining study workflows. Similarly, in diabetic retinopathy (DR) and macular edema (ME) cases, AI strengthens traditional grading methods, providing deeper insights into disease features through advanced imaging analysis.
Additionally, the webinar discusses the pivotal role of electronic clinical outcome assessments (eCOA) in acknowledging the patient voice and perspective. By implementing best practices for visually impaired patients and integrating validated design features like zoom in/out functionality, participants can seamlessly complete patient-reported outcomes (PROs), improving accessibility and minimizing bias in assessments.
Register for this webinar to explore strategies focused toward improving patient access and precision analysis by integrating artificial intelligence in ophthalmology clinical trials.
Speakers
Dr. Todd Rudo, MD, Chief Medical Officer, Clario
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety.
Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. 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 maintaining focus on the customer experience, including minimizing patient and site burden.
Dr. Amit Vasanji, PhD, Vice President, Medical & Scientific Affairs, Clario
Dr. Amit Vasanji has over 20 years of experience in basic and clinical research image acquisition, processing, analysis, visualization and biomedical software engineering across multiple modalities and therapeutic areas.
His research has been published in a broad array of peer-reviewed journals and he is frequently invited to speak at international events on effective workflow design and algorithm-based biomarker development for imaging-based clinical trials.
In his current role at Clario, Amit oversees the scientific feasibility and design of Clario’s imaging platform and is responsible for the development and integration of customized image analysis algorithms into clinical trial workflows.
Dr. Kelly Dumais, PhD, Director, eCOA Science and Consulting, 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 (eCOAs) 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.
Who Should Attend?
This webinar will appeal to professionals with the following job titles or those working in the following fields:
- CEOs/Chief Medical Officers/Scientific Officers
- Clinical Data Managers
- Clinical IT/Clinical Monitoring
- Clinical Operations (early phase)/Clinical Operations/Clinical Development/Clinical Research
- Clinical Pharmacologists/Clinical Scientists/Data Scientists/Imaging Scientists
- Digital health/Innovation/Operations/Health economics and outcomes research/Regulatory affairs
- Medical Affairs/Medical Monitor/Head of Development for Program
- Protocol Managers
- Sr. Managers, Trial Initiation
- TA experts in ophthalmology
What You Will Learn
Attendees will learn about:
- The importance of utilizing vendor-agnostic, multi-modality platforms in ophthalmology clinical trials to improve regulatory compliance, transparency and workflow efficiency, particularly through AI-enabled real-time analysis and reporting
- Review of case studies for conditions like AMD, DR and ME and how AI integration in clinical trials enhances traditional metrics, strengthens grading methods and provides deeper insights into disease features
- Incorporating the patient voice in clinical trials to understand patient symptoms and experiences, which has been a key area of interest by regulatory agencies and useful for providing key patient perspectives in patients with ophthalmic diseases using PRO assessments
- Importance of using best practices in collecting PROs in patients with visual impairments and how a new design feature (zoom in/out) makes it easier for patients with visual impairment to complete electronic patient-reported outcomes
Xtalks Partner
Clario
Clario is a leading healthcare research and technology company that generates the highest quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Clario’s science, technology, and operational experts have helped deliver over 26,000 trials and contributed to over 800 regulatory approvals in more than 100 countries. For more than 50 years, we have provided deep scientific expertise and the broadest endpoint technologies to help transform lives around the world.
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