PNAS – Proceedings of the National Academy of Sciences of the United States of America
Core Concept: The pandemic is prompting widespread use—and misuse—of real-world data
PNAS first published October 21, 2020. https://doi.org/10.1073/pnas.2020930117
… But harnessing this type of real-world data is a tricky business. It requires high-quality data collection and proper methodological considerations. There are established guidelines on how best to plan, execute, and report observational studies in a way that ensures the validity and relevance of the evidence gathered (1). Yet researchers and clinicians can sometimes neglect those guidelines, especially during a health crisis in which the rush to publish has spawned some suspect research practices, according to some observers.
The pandemic thus presents an unprecedented opportunity to leverage diverse, real-world data sources to inform medical and regulatory responses to the public health emergency. Yet, at the same time, says Almut Winterstein, a pharmacoepidemiologist from the University of Florida in Gainesville, the need for speed should not come at the expense of methodological rigor and detail.
“That’s [the] balance that needs to be maintained,” says Winterstein, who served as president of the International Society for Pharmacoepidemiology until this past August. “On the one hand, you need real-world data in order to have complete evidence for decision making. But at the same token, you have to follow proper epidemiological methods and consider and address the biases in the data before making any causal inferences.”…