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Clinical Outcome Assessment (COA)
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Term of the Day

Natural History Study

A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.

R

Real-world evidence (RWE)

Real-World Evidence (RWE) refers to data and evidence derived from real-world clinical practice, such as data from electronic health records (EHRs), claims databases, patient registries, and other sources of healthcare data.

RWE is distinct from data collected in controlled clinical trials, which are conducted under tightly controlled conditions with a specific patient population and a pre-defined set of inclusion and exclusion criteria. In contrast, RWE reflects the real-world experiences of patients in diverse healthcare settings, and can provide insights into the safety, effectiveness, and value of treatments in routine clinical practice.RWE is increasingly being used by healthcare stakeholders, including regulators, payers, and providers, to inform decision-making related to drug development, regulatory approvals, coverage decisions, and clinical practice guidelines. RWE can also be used to identify unmet medical needs, inform clinical trial design, and support post-marketing surveillance and safety monitoring.

Overall, RWE is a valuable source of data and evidence for understanding the safety, effectiveness, and value of healthcare interventions in real-world clinical practice, and is increasingly being used to inform healthcare decision-making across the healthcare ecosystem.