Harnessing the Power of Real‐World Evidence (RWE): A Checklist to Ensure Regulatory‐Grade Data Quality

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Excerpt

RWE is derived from the data of patients treated in real‐world settings. The surge of electronic health records (EHRs), as well as other technologies, enables researchers to better understand the real‐world patient experience. EHR‐derived data can be combined with other data sources such as administrative claims, genomic information, and mortality datasets to create a more complete description of a patient's cancer journey. It is crucial to develop rigorous guidance for translating real‐world data (RWD) into actionable and meaningful RWE.
Standardized criteria facilitate the evaluation of RWD and data analysis in order to establish the confidence level in an RWE result. This article furthers the ongoing discussion about RWE in healthcare by defining RWE, exploring potential use cases in cancer, and proposing a regulatory‐grade RWE checklist.
RWE is generated from RWD that are documented during the course of routine clinical care. With appropriate privacy and ethical processes in place, RWD can be gathered retrospectively, as commonly used for health outcomes research, or prospectively, as may be used for safety monitoring or a pragmatic trial.
While all RWD sources have their limitations, the richest in terms of depth and breadth is the EHR. Structured data, such as cancer diagnosis codes, can be easily extracted from the EHR with appropriate technological and software solutions. Abstraction of unstructured data, such as tumor histology from pathology reports, can supplement the core structured data elements.
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