Hospital-Based eCOA Implementation: Real Challenges In Infectious Disease Trials

Infectious disease trials face unique challenges that can derail timelines and compromise data quality. Unlike chronic conditions, symptoms in acute infections fluctuate rapidly — sometimes within hours — making standard weekly patient-reported outcome schedules ineffective. Hospital-based trials add further complexity with variable patient acuity, IT security hurdles, and infrastructure limitations that generic eCOA platforms often fail to address. Regulatory expectations heighten the stakes: endpoints must capture disease-specific symptoms like dysuria in UTIs or sputum changes in pneumonia, yet developing custom instruments can take 18–36 months.

Pre-validated tools such as PROMIS and adaptable libraries offer a faster path, but implementation requires strategic planning around IT integration, staff training, and device management. This resource outlines proven strategies to reduce delays, improve compliance, and meet regulatory standards for PRO data in infectious disease studies. Download now to learn how to avoid common pitfalls and accelerate trial success.