Zoom Webinar: Digital Trials – Charting a New Path for an Outdated System
Category: Clinical Research
Learning Objectives: Digital Clinical Trials
Description: Participating in clinical research is readily acknowledged as highly important to the patient health-focused mission of providers. Unfortunately, clinical trial methods to date have involved disparate workstreams and require considerable manual processes. The result is clinical trials that are expensive, time consuming, and not representative of real-world clinical practice and populations.
FDA is spearheading a call to action for new research paradigms that aim at providing a connection between real world data and clinical research. To this end, Optum established the Digital Research Network (DRN), an EMR-fueled integrated approach to clinical research that leverages both existing and new data and technology assets to accelerate clinical trials. The DRN model results in clinical studies that are faster, utilize fewer resources, and are more grounded in real-world clinical practice. The DRN partners with a tech-enabled network of provider sites that stream EMR and other patient data into a curated data repository.
In partnership with Innovo, a research organization that connects provider networks, the Optum DRN is running an end-to-end study through a completely digital process. In addition to implementing a digital approach to clinical operations, Innovo is testing Optum’s EHR-based study feasibility and patient finding application capabilities for their research program. The presentation will discuss the DRN as a model for digital clinical trials and describe the details of the current Optum/Innovo partnership, including processes performed to date and future directions.
Speakers with Short Bio:
Wilmington Health/Innovo Presenter:
Jeff James, MBA CPA, CEO, Wilmington Health and Innovo Research (Leadership)
Jeff James is CEO of Wilmington Health and its research venture, Innovo Research. He has over 20 years’ experience in large group practice administration. Jeff has been instrumental in developing Wilmington Health’s strategy related to Clinical research as a care option and population health countermeasure. Wilmington Health is a founding member of the Optum Digital Research Network.
Optum Digital Research Network Presenter:
Lauren Neighbours, PhD, RAC, VP, Regulatory Affairs and Program Management, Optum
Dr. Lauren Neighbours oversees regulatory strategy, compliance, and program management for the Optum Digital Research Network. She has 13+ years of research experience within industry, government, and academia. Dr. Neighbours has led multidisciplinary development programs from the pre-clinical stage through marketing. She has managed regulatory submissions and clinical studies, facilitated FDA meetings, and authored corporate SOPs.
Western Washington Medical Group Presenter:
Stephanie Abbott, Pharm D, Director of Research, Western Washington Medical Group
Dr. Stephanie Abbott has been a clinical investigator for nearly two decades. She is the managing partner for Western Washington Medical Group clinical research center and oversees clinical trials as the Director of Research. Dr. Abbott and Western Washington Medical Group are dedicated to the continual improvement of the delivery of clinical trials and is a proud partner in the Optum Digital Research Network.