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Público·3 miembros

The Role of Real-World Evidence in Clinical Trials

Real-world evidence (RWE) has become increasingly important in complementing traditional clinical trials. While randomized controlled trials remain the gold standard for evaluating safety and efficacy, they occur under controlled conditions that do not always reflect everyday patient experiences. RWE bridges this gap by incorporating data from routine medical practice.


Sources of RWE include electronic medical records, insurance claims, patient registries, wearable devices, and patient-reported outcomes. This data helps researchers understand how treatments perform outside controlled environments. For example, RWE can reveal long-term effects, adherence patterns, or differences in outcomes among diverse populations.


Integrating RWE into trial design enhances relevance and efficiency. Hybrid studies combine randomized elements with real-world data collection, allowing broader participation and faster insights. RWE also supports safety monitoring by identifying rare adverse events that may not appear in smaller trials.


RWE empowers patients by capturing their real-life experiences and priorities. It improves decision-making for clinicians, helping tailor treatments to individual needs. As data systems improve and transparency grows, RWE will continue shaping the future of evidence-based medicine.



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