Information collected from various sources outside of traditional clinical trials, reflecting the everyday experiences and outcomes of individuals in real-world settings.

Real-World Evidence (RWE):

The clinical evidence regarding the usage and potential benefits or risks of a medical product derived from the analysis of real-world data.

Electronic Health Records (EHRs):

Digital versions of patients’ paper charts, containing comprehensive health information, facilitating seamless data sharing among healthcare providers.

Pragmatic Trials:

Clinical trials designed to assess the effectiveness of an intervention under real-world conditions, providing insights into its practical application.

Patient Registries:

Systematic collections of standardized data about patients with a specific condition, providing a valuable resource for understanding disease patterns and treatment outcomes.

Data Harmonization:

The process of integrating and standardizing diverse data sets to ensure consistency and interoperability for meaningful analysis.

Endpoint Adjudication:

The systematic and independent review of clinical events or outcomes to ensure accuracy and reliability in research studies.

Bias and Confounding:

Factors that can distort the interpretation of real-world data, leading to incorrect conclusions about the effectiveness or safety of a treatment.

Data Privacy and Security:

Safeguarding individuals’ sensitive health information, ensuring compliance with regulations and ethical standards in the collection and use of real-world data.

Meta-Analysis of Real-World Studies:

A statistical method that combines results from multiple independent real-world studies to provide a comprehensive overview and strengthen the evidence base.