ROLE OF REAL-WORLD EVIDENCE IN CLINICAL RESEARCH

Shagufta Shaik*, Grandhi Raveena, Dr. Ankita Srivastava

ABSTRACT

Real-World Evidence (RWE) is increasingly important in clinical research, providing insights into treatment effectiveness, safety, and cost-effectiveness in real-world settings. By leveraging data from routine clinical practice, RWE complements traditional randomized controlled trials, offering a broader representation of patient populations and facilitating personalized medicine approaches. Integration of RWE expedites Evidence generation, enhances understanding of interventions' real-world impact, and informs clinical decision-making. Addressing data quality and privacy challenges is crucial for harnessing the full potential of RWE in clinical research. Real-World Evidence encompasses data from diverse sources, including electronic health records, insurance claims databases, patient registries, and wearable devices. By analyzing this vast and heterogeneous data, researchers can generate Evidence on treatment outcomes, patient characteristics, therapy adherence, and long-term safety profiles, among other factors. RWE can help identify subpopulations that may benefit the most from specific interventions, inform treatment guidelines, and support shared decision-making between healthcare providers and patients. RWE can fill the gaps left by RCTs, often conducted in controlled environments with limited sample sizes and restricted patient eligibility criteria. It can provide valuable insights into interventions' long-term effectiveness and safety and support regulatory decision-making, post-marketing surveillance, and comparative effectiveness research. In conclusion, Real-World Evidence plays a pivotal role in clinical research by complementing traditional study designs and offering a broader understanding of healthcare interventions in real-world settings. Leveraging its potential requires addressing methodological challenges and fostering collaboration among various stakeholders. By doing so, Real-World Evidence can contribute to more informed healthcare decision-making, improved patient outcomes, and advanced Evidence-based medicine.

Keywords: Real-World Evidence, clinical research, randomized clinical trials, regulatory affairs, Real-World Data.