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

Kinthada Ramesh; Shaik Neelofar

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

Authors:
Shaik Neelofar | Kinthada Ramesh

Cite This Article :

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, pp.821-832, URL: https://www.ijtsrd.com/papers/ijtsrd59813.pdf

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Abstract :
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.

Keywords :
real-world evidence, clinical research, regulatory decision-making, electronic health records, randomized controlled trials, safety, effectiveness, patient outcomes

Publication Details:

Unique Identification Number : IJTSRD59813

Published In : Volume-7 | Issue-4, August 2023

Page Number(s) : 821-832

Publisher Name : IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470

Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

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