As the transition to electronic health records continues, the interest in using real-world data to streamline research and connect clinical research and practice data grows with it, according to an article published in the Journal of the American Medical Association.
“The FDA routinely uses RWD to provide evidence about drug safety, drawing on claims and pharmacy data from more than 100 million individuals in its Sentinel System,” the article states.
The FDA Oncology Center for Excellence, in a bid to develop a more clear understanding of what role RWD could play in regulatory decisions, has entered into a partnership with Flatiron Health and the American Society of Clinical Oncology’s CancerLinQ, a big data initiative, according to the article.
“These and other FDA projects are assessing the completeness, accuracy, and consistency of electronic health data and will ultimately inform the FDA’s assessment of the fitness of these data for use in regulatory studies,” the article states.
To read the full article on JAMA, click here.