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The role of real-world evidence in health technology assessment decision-making: what differences between RWE and randomised controlled trials (RCTs) are highlighted in HTA guidelines, and how do these differences impact the assessment of effectiveness and safety? A systematic literature review
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Resumo(s)
This 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.
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Palavras-chave
Real-World Evidence RWE Health Technology Assessment HTA Randomized Controlled Trials RCTs RWE integration Decision-making Reimbursement Reimbursement decision Policy recommendations Best practices Case studies Guidelines Frameworks Standards International health systems Healthcare systems Methodological challenges Evidence-based decision-making