Abstract
Early phase oncology trials establish the safety of novel anti-cancer agents. However, clinician-assessed toxicity gradings may miss up to half of adverse events compared to patient reported events, leading to an incomplete picture of a drug’s tolerability. There is growing interest in PROs to enhance toxicity reporting and improve patient representation in drug development. However, little is known about PRO use in this setting. This study describes trends and characteristics of PRO use in early phase oncology trials.
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