Journal of Biometrics & Biostatistics

Real-World Data and Evidence: An Overview of Sources and Applications in Healthcare Research

Abstract

Androz Shina*

The generation of robust Real-World Evidence (RWE) from Real-World Data (RWD) and its integration into drug development and regulatory review poses a significant challenge for biostatisticians. Mapping RWE to substantial evidence description requires a rigorous analytical approach that takes into account the quality, validity, and relevance of the RWE generated from RWD. To achieve this, it is essential to apply appropriate statistical methods and data science techniques to analyze the RWD and generate reliable and actionable RWE. The recent European Union's General Data Protection Regulation (GDPR) is one example of a concept that has been defined in numerous ways. "Any information relating to an identified or identifiable natural person" is the definition of personal data in this. "racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic data, biometric data for the purpose of uniquely identifying a natural person, health data or data concerning the individual's sex life or sexual orientation" are all examples of sensitive data in this set. It is against the law to use automated means to process these kinds of data for any purpose at all without the explicit consent of the subject