Design considerations for observational studies of drugs for advanced cancer

X. García-Albéniz,P. Stattin,M. Westerberg,R. Weinrib,Per Sandstrom,Z. Vassilev

Published 2023 in Pharmacoepidemiology and Drug Safety

ABSTRACT

Key Points • Real-world evidence (RWE) studies are gaining relevance in the clinical development programmes of drugs for advanced cancer. • RWE studies of drugs for advanced cancer can be challenging because the study drug can be part of several of the many lines of treatment (LoTs) patients can receive, and occasionally, the component drugs of a LoT are not started concomitantly. • The target trial emulation framework can help in the design, analysis, and interpretation of RWE studies of drugs for advanced cancer.

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