Current Obstacles in Using Real-World Evidence and Policy-wise Efforts to Overcome Them

Summary

RWE was believed to advance RWD and its benefits. In reality, there are multiple barriers. Policies were established to overcome these barriers. The following table summarizes them:

Barrier Approach Policies
Data unrelated to compensation or reimbursement is poorly recorded Improve capture at data source
  • Provide compensation for physicians and health care organizations, such as providing CMS
  • Invest in AI that helps data capture
EHR does not provide complete, longitudinal data for individuals Enable access to longitudinal whole-person data
  • Allow health data exchange by modifying TEFCA
  • Implement a national all-payer claims database
  • Invest in organizations that can link data
Regulations Improve regulatory practices
  • Train FDA reviewers and inspectors
  • Fund regulatory research such as application of AI in regulation