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All data companies working in the healthcare industry are on a mission to help with the development of drugs and high-quality treatments while aiming for the best patient outcomes.
But, unlike controlled conditions under which clinical trials are conducted, real world data is collected from a variety of different sources. It is an unregulated but critical area of clinical research. That’s why many conversations around the standardization of this type of data have occupied data scientists’ attention. The FDA has recently released a document with guidance on how to use real-world data for regulatory submissions.
In this episode of Real World Talk, our host Zoe Li is joined by her colleagues, CK Wang, Laura Fernandes, and Andrew Belli, to discuss the draft guidance on RWD recently released by the FDA . They emphasize that it’s still draft guidance, and it is yet to be seen in which direction it will go. However, they all agree that it is essential to establish standards regarding how companies collect, analyze, and use real-world data that will contribute to clinical research.