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Real-world response endpoints in patients with mNSCLC treated with chemotherapy across real-world datasets

May 25, 2023


Response Evaluation Criteria in Solid Tumors (RECIST)-based response rate is used for efficacy evaluation in clinical trials and relies on imaging data collected at pre-specified time points for uniform assessment. However, in real-life clinical practice, how doctors measure the treatment’s effectiveness varies from patient to patient and across different medical practices. As such, the method and timing of response assessment varies, and imaging data from the electronic health record (EHR) and other real-world sources may not be available, making RECIST-based assessment of rw-response (rwR) using real-world data (RWD) difficult.

To address this issue, Friends of Cancer Research formed a multi-stakeholder collaboration with FDA and data partners to establish a framework for consistent evaluation of rwR across RWD sources.

Why this matters

Developing a reliable clinician-assessed real-world response endpoint can help regulators characterize drug effectiveness using RWD sources to inform regulatory decision-making.

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