Imaging Isn't Optional: What Sponsors Must Know To Safeguard Ocular Endpoints

Imaging plays a pivotal role in enhancing the efficacy and reliability of clinical trials, especially in the realms of GLP-1 therapies and neurology, where ocular endpoints require heightened sensitivity. Explore the necessity of incorporating imaging methodologies early in the trial design to improve data quality and overall trial efficiency.

The demand for precise imaging is underscored by the need to monitor micro-level changes, acquire real-time insights, and deliver dependable data to regulatory authorities. It differentiates between quantitative imaging, which yields objective numerical assessments, and qualitative imaging, which relies on subjective interpretation and may introduce variability in the absence of standardized protocols. This article advocates for an approach that aligns imaging protocols with each trial phase, from preclinical assessments to label expansions. Ultimately, it emphasizes that early integration of imaging within clinical trial protocols is vital for minimizing costs, reducing the need for rework, and ensuring timely completion of trials.