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Use of RWE to Inform Regulatory, Public Health Policy, and Intervention Priorities for the Developing World.

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Low- and middle-income countries (LMICs) can leverage real-world evidence (RWE) for healthcare policy and product registration. Challenges include data infrastructure and regulatory frameworks, but HIC RWE can be adapted to LMIC needs.

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Area of Science:

  • Health Policy
  • Real-World Data Science
  • Global Health

Background:

  • Low- and middle-income countries (LMICs) face challenges in utilizing real-world data (RWD) and real-world evidence (RWE).
  • Effective use of RWE/RWD is crucial for both regulatory decision-making and health policy development in LMICs.
  • The role of health product procurers in leveraging RWE/RWD is still evolving.

Purpose of the Study:

  • To identify challenges hindering RWE/RWD utilization in LMICs.
  • To explore the potential of adapting RWE/RWD from high-income countries (HICs) for LMIC contexts.
  • To inform strategies for enhancing RWE/RWD application in LMIC healthcare systems.

Main Methods:

  • The study reviews current practices and challenges in RWE/RWD adoption in LMICs.
  • It analyzes the indirect use of RWE generated in HICs by LMIC procurers.
  • It discusses the potential for adapting HIC RWE to LMIC populations and needs.

Main Results:

  • Key challenges for LMICs include the need for more electronic health records (EHRs), confounder adjustment, stakeholder trust, and supportive regulations for data use.
  • Procurers in LMICs currently use RWE indirectly, relying on HIC-generated evidence.
  • HIC RWE can be adapted to reflect LMIC phenotypic patterns and address unmet needs.

Conclusions:

  • LMICs must address infrastructural and regulatory hurdles to fully benefit from RWE/RWD.
  • Adapting existing RWE from HICs presents a viable interim strategy for LMICs.
  • Strategic adaptation of HIC RWE can help meet LMIC healthcare priorities and needs.