LAUSR

Key Points Question How do oncologists at large academic medical centers with experience pursuing expanded access (EA) to investigational medicines perceive this regulatory pathway and their role in it? Findings This qualitative study involved semistructured interviews with 25 adult and pediatric oncologists at 4 academic medical centers. Oncologists expressed confidence in determining whether an investigational treatment was the best option for their patients, based on their own experience and assessment of available data, independent of US Food and Drug Administration (FDA) approval status; when an investigational drug was determined to be the best option and trial enrollment was unavailable, oncologists indicated an obligation to pursue EA. Meaning These findings suggest that academic oncologists valued evidence in recommending treatments but did not report feeling compelled to wait for marketing approval from the FDA, raising questions about access to EA in community settings where oncologists may be further removed from emerging evidence.