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Real-world data is emerging as a source of data to evaluate drug effects that may provide unique benefits given the highly selected enrollment and participation of adult patients in clinical trials. This commentary considers the potential utility of real-world data in light of the recently reported results of the FLOWER study, which explore the safety and efficacy of osimertinib using a prospective single-arm design with real-world data sourced from clinical practice.

Blurring the Lines of Design: Prospective Observational Cohorts and Pragmatic Clinical Trials Characterizing Treatment Effects in Routine Cancer Care