What Does This Mean? The Hidden Complexity Of Ophthalmic Protocol Requirements

Explore the critical role of meticulously planning ophthalmic assessments in clinical trials, highlighting their potential risks and complexities. It cautions that underestimating these assessments can lead to inconsistent data quality, protocol deviations, fulfillment complexities, and cost overruns. Ophthalmic assessments range from basic screenings to advanced imaging, necessitating varying levels of specialist involvement and equipment.

A real-world example with fundus photography demonstrates how variations in camera resolution and dilation requirements can affect trial logistics and outcomes. This article introduces a diagnostic tool comprising seven essential questions to help sponsors evaluate the complexity of their trial's ophthalmic needs, addressing on-site equipment, assessment frequency, and staff certifications. Learn about the advantage of conducting trials at sites with specialized resources and affiliations, which are better equipped for complex assessments. Sponsors are encouraged to conduct a risk assessment to determine study risk levels, influencing the need for specialized partners and budget planning. Take steps to position your clinical trial for smoother execution and more reliable data with support from 20/20 Onsite.