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C
Clinical Outcome Assessment (COA)
C
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C
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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 data (RWD)

Real-World Data (RWD) refers to data collected in routine clinical practice, outside the context of controlled clinical trials. RWD can come from a variety of sources, including electronic health records (EHRs), claims databases, patient registries, and other healthcare data sources.Unlike data collected in controlled clinical trials, RWD reflects the diversity of patient populations and healthcare settings, and can provide insights into real-world treatment patterns, patient outcomes, and healthcare costs.

RWD is increasingly being used to inform healthcare decision-making, including drug development, regulatory approvals, coverage decisions, and clinical practice guidelines. One of the challenges of using RWD is ensuring the quality and completeness of the data, which can vary widely depending on the source and the quality of data capture. Additionally, the use of RWD may raise privacy and security concerns, and require careful management of patient data to ensure confidentiality and compliance with applicable regulations.