FDA’s Real-World Evidence Guidance Warns Of Potential Pitfalls

FDA cautions in its final guidance on use of real-world data that drug sponsors who want to use routinely generated health records as part of evidence for a regulatory decision should be aware of factors like missing data, cofounding factors and sampling bias. The leader of one company focused on real-world evidence says while FDA has high data standards, artificial intelligence can help in combing through records and identifying meaningful evidence. The guidance released this week includes detailed recommendations on...