Guiding Principles for Real World Data and Evidence Generation

This document is a technical report detailing the guiding principles for the use of real-world data (RWD) in generating real-world evidence (RWE) relevant to drug development and regulatory decisions. It outlines the importance of high-quality RWD in evaluating drug effectiveness and safety. The report identifies various sources of RWD, including hospital information systems, health insurance payment data, and active monitoring data for drug safety. It discusses the challenges in RWD applications, such as data quality control and the need for standardized data models. Additionally, the document emphasizes the significance of data governance, compliance, and quality management systems in ensuring the reliability of RWD. It aims to provide specific requirements and guidance for managing data, assessing its suitability, and preparing for the production of valid RWE to support drug regulatory decisions. The report also includes a bibliography and appendices for further reference.