薬経済学: オープンアクセス

Integration of Real-World Data and Clinical Trial Data: Implications for Clinical Data Management

Abstract

Gunter Frass*

Clinical trials have long been the gold standard for generating evidence about the safety and efficacy of new drugs and medical treatments. However, as the healthcare landscape continues to evolve, there is a growing recognition of the need to Integrate Real-World Data (RWD) with Clinical Trial Data (CTD) to gain a more comprehensive understanding of a treatment's performance. This integration has significant implications for clinical data management, as it presents both opportunities and challenges that must be carefully navigated. Clinical Data Management (CDM) is a critical component of the drug development process. It involves the collection, processing, and analysis of data generated during clinical trials to ensure data quality, accuracy, and compliance with regulatory standards. Traditionally, clinical trials have relied solely on CTD, which are collected under controlled and highly monitored conditions. However, this approach has limitations, including limited generalizability to real-world patient populations and settings.