Zhaohui Su, VP of Biostatistics at Ontada, shared a post on LinkedIn:
“Real-world data (RWD) is critical for research and decision-making by providing information captured during routine patient care through electronic health records (EHR), insurance claims, and other sources. Traditional clinical trials often face challenges such as a lack of diversity, limited patient access, and failure to represent real-world populations, particularly for rare cancers and diseases.
RWD addresses these issues by facilitating retrospective, standard-of-care studies that use real-world patient data as control groups. This method can expedite drug development, especially when prospective randomized trials are not feasible.
A significant example of this is McKesson’s 2017 contribution of RWD analyses that supported the first FDA approval of a first-line therapy for metastatic Merkel Cell Carcinoma.
Furthermore, RWD enhances precision medicine by enabling clinicians to assess how patients with specific genetic mutations respond to treatments outside of trial settings. With deeper insights into effectiveness, safety, and comorbidities, RWD and real-world evidence (RWE) are increasingly acknowledged as essential tools that foster innovation and ultimately save lives.”
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