How to Collect Real-World Data and Provide Evidence to FDA/Notified Body/MHRA

🔍 What is Real-World Data?

Real-world data (RWD) refers to health information gathered outside the controlled settings of clinical trials, such as from electronic health records (EHRs), claims data, patient registries, wearable devices, and patient-reported outcomes. This type of data captures a broad range of patient experiences across various conditions and real-life situations, providing insights that traditional clinical trials may not.

📊 Types of RWD and Their Applications:

• EHRs: Diagnoses, medication lists, lab results used for tracking treatment patterns and outcomes.
• Claims Data: Procedure codes and billing information for analyzing healthcare utilization.
• Patient Registries: Tracking long-term outcomes in specific disease areas.
• Wearable Devices: Monitoring health metrics like heart rate and physical activity.
• PROs: Capturing patient experiences, quality of life, and treatment satisfaction.
• Mobile Apps and Social Media: Identifying emerging health trends and patient perspectives.
  
  

🛠️ Best Practices for Collecting RWD:

1. Develop a Clear Data Collection Strategy:
   • Define research objectives, identify data sources, and allocate resources.
2. Implement Data Governance and Quality Control:
   • Standardize data definitions, automate quality checks, and maintain audit trails.
3. Ensure Data Privacy and Security Compliance:
   • Anonymize data, enforce access controls, and conduct regular compliance training.
4. Use Standardized Data Models and Terminologies:
   • Adopting models like OMOP and using vocabularies like SNOMED CT ensures data consistency and regulatory compliance.
5. Validate Data Sources and Methods:
   • Verify data sources, conduct pilot testing, and perform ongoing monitoring.
     
     

📋 Why RWD is Crucial for Regulatory Submissions:

• Complementary Evidence: Supports traditional clinical trial data.
• Post-Market Surveillance: Monitors safety and identifies rare adverse events.
• Expanding Indications: Facilitates approval for new drug/device uses.
• Cost-Efficiency: Enables rapid and less expensive evidence generation.
  
  

RWD helps regulatory bodies like the FDA, MHRA, and EMA make informed decisions by providing insights into real-world patient outcomes. It is increasingly considered for regulatory submissions, especially in areas like post-market surveillance and expanded indications.

💡 How RWD Benefits Various Stakeholders:

• Medical Device Manufacturers: Supports CE marking and MDR compliance.
• Pharmaceutical Companies: Informs drug development and label expansions.
• Healthcare Providers: Enhances clinical decision-making, personalized care, and quality improvement initiatives.
  
  

RWD is transforming healthcare by providing valuable insights that complement traditional clinical trials. This whitepaper outlines the best practices for collecting and leveraging RWD to meet regulatory requirements effectively.

📥 Download the whitepaper now to learn how to optimize RWD collection and regulatory submission processes!