The latest episode of New Insight with Veeral Sheth, MD features a conversation with Brad Doerschuk, the CEO of InFocus Clinical Research, on the important role of contract research organizations in ophthalmology research.
0:00 Introduction
0:52 What is a CRO?
2:13 Development of InFocus
6:45 Discussing the retina pipeline
11:46 Recruitment challenges, solutions
15:50 Developing new clinical trial sites
18:19 Relationship between investigators, CROs
19:56 Shift in FDA guidance
23:14 New trial endpoints
25:16 Conclusion
In the medical community, a revolving cast of players is pivotal in advancing scientific discovery and enhancing patient outcomes. During the research stage, a collaborative team effort, from the clinical trial sponsors to research sites and patient populations, is essential to ensure smooth progress and sustain momentum toward the finish line.
In the latest episode of New Insight with Veeral Sheth, MD, Veeral Sheth, MD, director of clinical trials at University Retina, hosts a conversation with Brad Doerschuk on the important role of contract research organizations (CROs) in retina and the field of ophthalmology.
Doerschuk is the chief executive officer of InFocus Clinical Research, a CRO specializing in clinical research and development in retina. Founded by Doerschuk and a group of retina stakeholders in 2015, InFocus combined clinical development with expertise to address the needs of an exploding field of retina studies and clinical drug development.
In their conversation, Sheth and Doerschuk shed light on the role of CROs in managing clinical trials, emphasizing their extensive service provision, including clinical project management, site monitoring, medical monitoring, drug safety, biostatistics, data management, and regulatory affairs.
The two stakeholders dive into the evolution of the retina space in recent decades owing to its explosion of clinical development, from anti-vascular endothelial growth factor (VEGF) agents for age-related macular degeneration to the new complement inhibitor class for geographic atrophy. Doerschuk also pointed to recent advancements in gene therapy, including promising trial data for inherited retinal diseases, as an indication of the growth of development in retina.
Sheth and Doerschuk emphasized the surge in clinical trials and noted the challenges in recruiting for trials on new agents, particularly as recent approvals became standard-of-care medications. They urged the need for committed investigators and coordinators like CROs to facilitate clinical trials and help in these recruitment efforts.
In discussing this facilitation, they explored the rapid changes in US Food and Drug Administration (FDA) guidance and the shift toward alternative endpoints, outside of traditional measures like best-corrected visual acuity (BCVA). The two men discussed what they anticipate at upcoming meetings, particularly early-phase data on unmet needs without treatments.
As the rest of the ophthalmology community anticipates meeting season, this episode of New Insight sets the stage for an in-depth look into the dynamic landscape of retina research and the collaborative efforts required to drive innovation and improve patient outcomes.
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Direct all podcast-related inquiries to show producer Connor Iapoce and keep an eye out for more from New Insight!
