The European Medicines Agency (EMA) has launched a public consultation on the draft chapter dedicated to real-world data (RWD) within the Data Quality Framework for EU medicines regulation. This is essential for advancing the use of real-world evidence in regulatory decisions. The draft RWD chapter aims to provide guidance on evaluating the quality of real-world data in medicines assessment. Moreover, it offers recommendations on employing metrics to assess data quality, ensuring reliable data collection systems and processes, and defines criteria for determining data relevance in addressing specific research questions. Focusing on rare diseases, the document highlights the importance of fitness-for-purpose: RWD source should align with the research question, not vice versa. Rare diseases are often underrepresented in RWD sources, leading researchers to refine the research question to fit the available data, although this is not considered best practice.
Input of stakeholders are strongly encouraged, particularly those involved in the planning, conduct, or analysis of non-interventional studies using real-world data, and in the field of data science, especially pertaining to medicine regulation.
Submissions can be made via an online questionnaire until 31 January 2025.