Regulatory Development, Adoption, and Perseverance of Real-world Evidence with global health authorities
Year: 2024
Type: article
Abstract: Real-world evidence (RWE) has gained significant attention as a valuable source of evidence in healthcare decision-making. This article provides a comprehensive analysis of the regulatory development, adoption, and perseverance of RWE with global health authorities, as well as a synopsis of the major trends and practices among global health authorities. The aim is to shed light on the current landscape, and prospects of utilizing RWE in regulatory processes. Globally, many health authorities are drafting guidelines for RWE and implementing various regulations. Implementation is in the initial stages because RWE has certain limitations. This article examines the experiences of selected global health authorities in the development and implementation of RWE strategies. It also examines regulatory guidelines, pilot programmes, and collaborations designed to establish a solid foundation for the use of RWE. However, despite all challenges and limitations, RWE is widely being used in drug approval and commercial sense.
Authors: Sanyam Gandhi, Kinshuk Saxena, C Kartikeyan, Akhilesh Tiwari, Sachin Jain, Vikas Jain, Pradeep Pal
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: diamond
OpenAlex ID: W4403169683