Real world evidence studies: Perspective on study design and regulatory framework for RWE
1 Medical and Regulatory Affairs, Guerbet Asia Pacific Ltd, Hong Kong.
2 Regulatory Affairs & Quality Management, Shiseido Asia Pacific Pte Ltd, Singapore.
3 Physiology, Grant Medical College, Sir J J Group of Hospital, Mumbai, Maharashtra, India.
4 Physiology, GMERS Medical College, Valsad, Surat, Gujurat, India.
5 Clinical Science, Biomea Fusion, Inc, USA.
6 Physiology, Vedanta Institute of Medical Sciences, Dahanu, Maharashtra, India.
7 Clinical Science, Shrewsbury, Massachusetts, USA.
Review Article
World Journal of Advanced Research and Reviews, 2023, 19(01), 235–245
Article DOI: 10.30574/wjarr.2023.19.1.1280
Publication history:
Received on 12 May 2023; revised on 30 June 2023; accepted on 01 July 2023
Abstract:
There is a growing need for broader information on Real-World Effectiveness and safety of any new intervention, service or protocol vs data limited by standardized and strictly controlled environment like in a RCT. RWE studies gives the freedom for analysis based on a varied and diverse database. As Real-World Studies gain higher acceptance, it is important to understand the types of RWE studies and design that can be used. Data from real-world patient experience has the potential to improve the quality and delivery of medical care, impact overall costs and outcomes. This review helps understand study designs, issues, and its implications in improving medical services. Though the RWE is challenged by diversity of information, large data sets of uncertain quality, and methodological rigor, however if utilized properly has potential to shape policies, protocols and develop programs to implement best practices.RWE has many issues including Legal, technological, data privacy, transparency, and standardization. These challenges can be and necessarily need to be addressed while planning the RWE which would then vastly enhance the acceptance of the evidence generated by RWE. Several researchers, professional societies, government agencies and multi-stakeholder initiatives worldwide have disseminated guidance, framework, and standards in this aspect which can address gaps in data standardization and improve the quality of RWD
Keywords:
Real world Evidence RWE; Real World data RWD; Regulatory framework OPTIMAL; SPIFD; Pragmatic Trials; Explanatory Trials; Retrospective trials; Prospective trials; Cross sectional studies; Case control studies; cohort Studies
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Copyright © 2023 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0