Barros, Pedro PitaLeite, JoãoMüller, Tizian Julius2025-03-282025-03-282025-01-062024-12-17http://hdl.handle.net/10362/181621This Systematic Literature Review (SLR) investigates the integration of Real-World Evidence (RWE) into Health Technology Assessment (HTA) processes to address the limitations of Randomized Controlled Trials (RCTs) in healthcare decision-making. The SLR examines methodological, data quality, and regulatory factors influencing RWE adoption across diverse healthcare systems. The findings reveal significant variability in HTA practices across countries, highlighting barriers such as inconsistent frameworks and limited interoperability. By synthesising evidence, this research underscores RWE’s potential to complement traditional evidence, improve patient access, and inform reimbursement decisions, supporting global efforts to optimise HTA methodologies and promote equitable healthcare policies.engReal-World EvidenceRWEHealth Technology AssessmentHTARandomized controlled trialsRCTsRWE IntegrationDecision-makingReimbursementReimbursement decisionPolicy recommendationsBest practicesCase studiesGuidelinesFrameworksStandardsInternational health systemsHealthcare systemsMethodological challengesEvidence-Based Decision-MakingThe role of real-world evidence in health technology assessment decision-making: best practices and lessons from successful RWE implementation - a systematic literature reviewmaster thesis203927370