Abstract
Introduction: Randomized controlled trials (RCT) and real-world evidence represent complementary approaches in clinical research, each with distinct strengths and limitations. Randomized controlled trials (RCT) are regarded as the gold standard for establishing efficacy because of their rigorous design and control over variables, but they are often criticized for limited generalizability to broader patient populations. In contrast, real-world evidence (RWE), derived from routine clinical practice, captures outcomes across diverse, heterogeneous populations and settings, enhancing applicability to clinical decision-making.
Discussion: This manuscript reviews the advantages and limitations of both methodologies, emphasizing their complementary roles in generating robust evidence. RCTs offer strong internal validity through randomization, blinding, and strict eligibility criteria, while RWE provides external validity by reflecting patient diversity, long-term outcomes, and care patterns in everyday practice.
Conclusion: Early clinical experience with a three-dimensional acellular wound matrix illustrates how registry-derived RWE can complement ongoing RCTs in wound care. This dual evidence strategy underscores the importance of aligning trial rigor with real-world complexity to generate clinically relevant, patient-centered data that further supports innovation, regulatory pathways, and reimbursement frameworks.