The Real-World Data Challenges Radar: A Review on the Challenges and Risks regarding the Use of Real-World Data

Digital Biomarkers

Enkelejda Miho¹  Lmar Babrak¹  Bettina Schneider²  Frank Grimberg²  Petra Maria Asprion²  Ali Habbabeh² 

[1] Institute for Medical Engineering and Medical Informatics, School of Life Sciences, FHNW University of Applied Sciences and Arts Northwestern Switzerland, Muttenz, Switzerland;Institute of Information Systems, Competence Center Cyber Security and Resilience, School of Business, FHNW University of Applied Sciences and Arts Northwestern Switzerland, Basel, Switzerland;

关键词: real-world data;    real-world evidence;    data quality;    risk;    compliance;   

DOI  :  10.1159/000516178

来源: DOAJ

【 摘 要 】

Background: The life science industry has a strong interest in real-world data (RWD), a term that is currently being used in many ways and with varying definitions depending on the source. In this review article, we provide a summary overview of the challenges and risks regarding the use of RWD and its translation into real-world evidence and provide a classification and visualization of RWD challenges by means of the RWD Challenges Radar. Summary: Based on a systematic literature search, we identified 3 types of challenges – organizational, technological, and people-based – that must be addressed when deriving evidence from RWD to be used in drug approval and other applications. It further demonstrates that numerous different aspects, for example, related to the application field and the associated industry, must be considered. A key finding in our review is that the regulatory landscape must be carefully assessed before utilizing RWD. Key Messages: Establishing awareness and insight into the challenges and risks regarding the use of RWD will be key to taking full advantage of the RWD potential. As a result of this review, an “RWD Challenges Radar” will support the establishment of awareness by providing a comprehensive overview of the relevant aspects to be considered when employing RWD.

【 授权许可】

Unknown