Real-World Evidence: Methodologies for Integrating Real-World Data into Clinical Research Frameworks.

Real-world evidence (RWE), derived from real-world data (RWD), is transforming clinical research by complementing traditional randomized controlled trials. With diverse data sources such as electronic health records, patient registries, and wearable devices, RWE offers insights that reflect everyday clinical practice. Despite challenges like unstructured data, bias, and privacy concerns, advances in artificial intelligence, machine learning, and data standardization enable meaningful analysis. Regulatory frameworks, including India's Digital Personal Data Protection Act, reinforce ethical use of patient data. By refining methodologies and fostering collaboration, RWE provides valuable evidence for regulatory decisions, personalized medicine, and enhanced patient care outcomes.