Quality of real-world registry studies

Area of Science:

• Health Services Research
• Clinical Epidemiology
• Regulatory Science

Background:

• Real-world studies (RWS) generate clinical evidence on therapeutic products in routine practice.
• Real-world data (RWD) used in RWS are collected for patient care, not strict clinical trial standards.
• Challenges exist in ensuring data quality, integrity, and reliability when using RWD.

Purpose of the Study:

• To identify critical elements for ensuring quality in planning and conducting registry studies.
• To emphasize the importance of data quality, integrity, and reliability in RWS.
• To support the generation of robust clinical evidence for regulatory decision-making.

Main Methods:

• This is a brief review discussing critical elements for quality assurance.
• Focuses on the planning and conduct phases of registry studies.
• Highlights best practices for reporting RWS.

Main Results:

• Key elements for ensuring quality in RWS planning and conduct were identified.
• Emphasis placed on rigorous data quality checks and validation processes.
• Importance of transparent reporting for evidence reliability.

Conclusions:

• Ensuring quality in registry studies is paramount for generating trustworthy real-world evidence.
• Proactive measures during planning and conduct are essential for data integrity.
• High-quality RWS support informed therapeutic use and regulatory decisions.