Authors
Brittany A. McKelvey, Elizabeth Garrett-Mayer, Donna R. Rivera, Amy Alabaster, Hillary S. Andrews, Elizabeth G. Bond, Thomas D. Brown, Amanda Bruno, Lauren Damato, Janet L. Espirito, Laura L. Fernandes, Eric Hansen, Paul Kluetz, Xinran Ma, Andrea McCracken, Pallavi S. Mishra-Kalyani, Yanina Natanzon, Danielle Potter, Nicholas J. Robert, Lawrence Schwartz, Regina Schwind, Connor Sweetnam, Joseph Wagner, Mark D. Stewart, and Jeff D. Allen
Purpose
Real-world data (RWD) holds promise for ascribing a real-world (rw) outcome to a drug intervention; however, ascertaining rw-response to treatment from RWD can be challenging. Friends of Cancer Research formed a collaboration to assess available data attributes related to rw-response across RWD sources to inform methods for capturing, defining, and evaluating rw-response.
Materials and Methods
This retrospective noninterventional (observational) study included seven electronic health record data companies (data providers) providing summary-level deidentified data from 200 patients diagnosed with metastatic non–small cell lung cancer (mNSCLC) and treated with first-line platinum doublet chemotherapy following a common protocol. Data providers reviewed the availability and frequency of data components to assess rw-response (ie, images, radiology imaging reports, and clinician response assessments). A common protocol was used to assess and report rw-response end points, including rw-response rate (rwRR), rw-duration of response (rwDOR), and the association of rw-response with rw-overall survival (rwOS), rw-time to treatment discontinuation (rwTTD), and rw-time to next treatment (rwTTNT).
Results
The availability and timing of clinician assessments was relatively consistent across data sets in contrast to images and image reports. Real-world response was analyzed using clinician response assessments (median proportion of patients evaluable, 77.5%), which had the highest consistency in the timing of assessments. Relative consistency was observed across data sets for rwRR (median 46.5%), as well as the median and directionality of rwOS, rwTTD, and rwTTNT. There was variability in rwDOR across data sets.
Conclusion
This collaborative effort demonstrated the feasibility of aligning disparate data sources to evaluate rw-response end points using clinician-documented responses in patients with mNSCLC. Heterogeneity exists in the availability of data components to assess response and related rw-end points, and further work is needed to inform drug effectiveness evaluation within RWD sources.
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