AJMC June 21, 1969
Jennifer B. Christian, PharmD, MPH, PhD

Real-world evidence (RWE) has become a significant enabler in research to measure the benefits and risks associated with oncology treatments in development. With the growing number of rare and aggressive cancers stratified by molecular subtypes, it becomes especially important to find alternative solutions for clinical development pathways when clinical trials are not possible.

In response, RWE has emerged as a valuable complementary resource to provide information beyond what is learned from randomized clinical trials. For single-arm trials, RWE can provide comparative context for interpreting results on the safety and efficacy of medical products. RWE is also enabling researchers to extend the follow-up of patients beyond the limits of a trial with observational, “lighter-touch” periods of follow-up, which allow for longer-term...

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