Table 1.
A checklist for ensuring regulatory-grade RWE (19).
| Checklist Item | Explanation |
|---|---|
| High quality | “The provenance of each data point must be clear, traceable, and auditable. Data quality must be systematically measured with predetermined frameworks (e.g., interrater reliability) and against benchmarks (e.g., stage distribution in SEER).” |
| Complete | “Completeness requires predefined rules for abstraction of structured and unstructured data, data harmonization, and quality monitoring. Completeness needs to be benchmarked to appropriate gold standards (e.g., National Death Index for date of death).” |
| Transparent | “Transparent study designs and analysis plans are critical for robust RWE. In particular, the specific aims and cohort selection criteria need to be precisely defined. Study design considerations include retrospective vs. prospective data collection, the need for matching or propensity scores to facilitate comparisons, and endpoint validation.” |
| Generalizable | “RWE is often based on a broad range of patients, which can translate into better generalizability. Potential biases (e.g., geographic representation) must be identified and reported to allow for appropriate statistical adjustments and clinical interpretations.” |
| Timely | “RWE reflects daily clinical decisions. Thus, reliable RWE needs to be recent and timely. Details about the timepoint that the data analysis represents must be reported (e.g., time period, last update, number of potential candidates, etc.).” |
| Scalable | “Data challenges become exponentially more complicated as the number of patients and variables increase. Therefore, scaling requires 1) a balance between high touch and automation; 2) a modular data model that can be used in multiple contexts and facilitates model evolution (e.g., frequency of intravenous regimens); and 3) unambiguous variable definitions, particularly for endpoints.” |
RWE, real-world evidence; SEER, Surveillance, Epidemiology and End Results. “Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality” by Miksad RA et al. is licensed under CC BY-NC 4.0.