Monitoring requirements for Real-World Evidence (RWE) studies may differ from those of traditional randomized controlled trials due to the nature of data collection and the sources of data involved.
 
According to recent (2021) draft FDA Guidance: Study monitoring may be focused on maintaining the reliability of the RWD and data integrity, beginning with extraction of the data from its origin through data curation and transformation and reporting of results.
 
Here are the key monitoring considerations for RWE studies:
 
[1] Data Quality and Integrity: This is the core of any monitoring activity. In RWE studies, data is often sourced from electronic health records, claims databases, registries, or directly from patients. The accuracy and consistency of this data should be monitored to ensure its validity. This can involve cross-checking data from different sources, checking for missing or inconsistent data, and using statistical methods to identify potential data errors.
 
[2] Regulatory Compliance: Even though RWE studies often use pre-existing data, they still need to comply with relevant regulations. For example, patient data must be handled in accordance with data protection laws such as the General Data Protection Regulation (GDPR) in the EU or the Health Insurance Portability and Accountability Act (HIPAA) in the US.
 
[3] Protocol Adherence: While protocol deviations may be less of a concern with RWE studies than with traditional trials (since there is no intervention being delivered), it’s still essential to monitor whether the study is being conducted as planned. For example, are the correct data elements being collected, and is the data being analysed according to the pre-specified plan?
 
[4] Safety Monitoring: Even though RWE studies are typically observational and don’t involve interventions, they still need to monitor for any potential safety signals that emerge. For instance, if the study involves a drug or device, any adverse events or side effects reported in the data nust be investigated.
 
[5] Ethical Compliance: Even though the patients involved in RWE studies may not be directly participating in the way they would in a clinical trial, ethical considerations still apply. If the study involves direct contact with patients (e.g., via surveys), the consent process and protection of patient rights should be monitored.
 
[6] Analysis and Reporting: As data is collected and analysed, it should be checked for completeness and accuracy. Any interim analyses or final reports should be reviewed to ensure they accurately represent the data collected and follow the pre-specified analysis plan.
 
In summary, while the specifics of monitoring may vary somewhat, the goal remains the same: to ensure the study is conducted with high standards of quality, integrity, and ethics, and that the data collected is reliable and valid.