The Role of Real World Evidence in Clinical Research and Regulatory Decision Making

In recent years, the utilization of real world evidence RWE has gained prominence as a valuable source of information in the realm of clinical research and regulatory decision making. This paper explores the multifaceted role that RWE plays in enhancing the understanding of medical products and their effects beyond traditional randomized controlled trials RCTs . RWE encompasses data derived from various sources, including electronic health records, claims databases, patient registries, and wearable devices. Through the integration of RWE, researchers and regulatory agencies can address questions that may not be feasible or ethical to explore through RCTs alone, providing insights into long term safety, effectiveness, and real world outcomes. Shaik Neelofar | Kinthada Ramesh "The Role of Real-World-Evidence in Clinical Research and Regulatory Decision-Making" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, URL: https://www.ijtsrd.com/papers/ijtsrd59813.pdf Paper Url:https://www.ijtsrd.com/other-scientific-research-area/other/59813/the-role-of-realworldevidence-in-clinical-research-and-regulatory-decisionmaking/shaik-neelofar