eCOA/ePRO Landscape: Covid-19 Impact

By Donna Mongiello RN, BSN, Vice President of Strategic Solutions, YPrime

The disruption caused by the coronavirus pandemic necessitated significant changes to the way we all work and live. The pandemic also may be the catalyst to examining how we can quickly adapt to crises that impact the drug development industry and speed up adoption of technological tools to meet current and long-term needs.

Many biopharmaceutical companies had to decide whether to suspend, modify, or even cancel their existing clinical trials. They had to reprioritize their 2020 pipelines which had been years in the planning, and this meant pushing out some trials and cancelling others due to the addition of new treatment or vaccine studies for COVID-19. Sponsors who were already using technology to collect clinical outcome assessments electronically in their clinical trials had fewer disruptions in keeping COA data collection flowing.

By mid- to late March 2020, when stay at home orders were enacted in hot spots like New York and New Jersey, many of the sponsors we support started to inform us of site closures and many scenarios where, due to lockdowns or patient health concerns, patients were no longer able or willing to attend site visits. This led to questions from our sponsors regarding how we could collect site-based data from patients at home. Knowing web-based data collection is the most desirable for ensuring patient safety and data integrity we quickly came up with a solution for our clients.