Summary of: Ma, X., Bellomo, L., Magee, K. et al. Characterization of a Real-World Response Variable and Comparison with RECIST-Based Response Rates from Clinical Trials in Advanced NSCLC. Adv Ther (2021).
Treatment effectiveness metrics for real-world research, similar to those assessed in clinical trials, are needed in order to generate interpretable RWE fit to support decision making during clinical development or regulatory processes.
Flatiron researchers set out to develop a real-world response (rwR) variable by capturing the clinician’s interpretation of radiographic assessments of solid tumor burden from information contained in EHRs and to evaluate its clinical relevance.
This study shows that EHR data curation can be leveraged to generate a feasible and reliable rwR variable, and associated endpoint (real-world response rate (rwRR)) analyses show that this variable is clinically meaningful. This type of research can help to fully realize the potential value of EHR-derived data.