Modernizing Vaccine Trials By Leveraging eCOA And Harnessing Innovation

By Lauren Crooks, Stephan Bart, and Marcela Roy

The COVID-19 pandemic accelerated innovation in vaccine development, highlighting the need for rapid, safe, and effective strategies to address both emerging and existing infectious diseases. Modern vaccine trials increasingly rely on electronic clinical outcome assessment (eCOA) platforms to capture longitudinal patient-reported data on immunogenicity and reactogenicity, improving data quality, participant retention, and regulatory compliance. Decentralized and bring-your-own-device (BYOD) approaches further enhance trial accessibility and engagement, allowing participants to report outcomes remotely and on familiar devices, while reducing the burden of on-site visits. Artificial intelligence (AI) and machine learning (ML) are also transforming vaccine development across multiple stages — from antigen target identification and vaccine candidate design to preclinical evaluation, clinical trial optimization, and supply chain management.

These technologies enable faster decision-making and improved trial efficiency but require high-quality data, bias mitigation, and transparent ethical frameworks. Additionally, wearable devices are increasingly integrated into vaccine trials to collect objective physiological data such as heart rate, fever, and sleep patterns, enhancing safety monitoring and capturing functional outcomes often missed by traditional endpoints. Together, these digital health technologies and innovative methodologies are reshaping how vaccine trials are designed, conducted, and monitored.