Executive Summary: In response to the COVID-19 pandemic, the use of real-world data (RWD) for research accelerated, supporting the global response to the COVID-19 pandemic via conduct of rigorous studies on the safety and effectiveness of diagnostics, drug repurposing, and novel therapies and vaccines in near real time. The use of RWD has many advantages, most notably that data typically are collected as a part of routine health care and are available expeditiously and often for large populations. However, there are special considerations for the use of these data for the secondary purpose of research. To learn from the evolving lessons of addressing the COVID-19 pandemic and to bolster the future use of real-world evidence (RWE), we created this primer to describe the RWD ecosystem. We included key principles of study design and potential sources of bias, examples of COVID-19 studies that use RWD, and mechanisms for disseminating RWE gleaned from the conduct of RWD research. We also introduce the COVID-19 Evidence Accelerator initiative that was established during the pandemic to support RWD study conduct.

Access the full Primer here.