Results 261 to 270 of about 3,960,591 (302)
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Real-World Evidence in the Real World: Beyond the FDA
American Journal of Law & Medicine, 2018The 21st Century Cures Act (“Cures Act”) relies on the concept of real-world evidence (“RWE”) to improve the Food and Drug Administration (“FDA”) approval process. This has amplified interest and furthered momentum in applying RWE more broadly, beyond FDA regulation.
Joan H, Krause, Richard S, Saver
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[Real-world evidence vs EBM: what does real-world data add?]
Recenti progressi in medicina, 2021Although randomized clinical trials (RCTs) offer the highest level of scientific evidence, they are unable to evaluate the impact of treatments in the routine clinical practice. The heterogeneity of socio-demographic and clinical characteristics of patients, as well as the complexity of treatments, explain the gap between the effect observed in RCTs ...
Franchi M., Corrao G.
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Real-world data and real-world evidence
Abstract Real-world data (RWD) can be described as routinely collected data from a variety of sources other than traditional clinical trials. A summary of the status of the use of real-world evidence (RWE) in regulatory decision-making is provided.Phil Ambery +2 more
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Real-world evidence enhances decision making
Journal of Managed Care & Specialty Pharmacy, 2020DISCLOSURES: No funding supported the writing of this commentary. The author has nothing to disclose.
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Real-world Evidence Simplified for Clinicians
Journal of The Association of Physicians of IndiaReal-world evidence (RWE) is rapidly becoming a crucial component in healthcare decision-making, complementing traditional clinical trial data. Randomized controlled trials (RCTs) are widely regarded as the most reliable method for assessing the efficacy and safety of medical treatments. RWE can enhance and support the results obtained from traditional
Abhijit Anil, Trailokya +5 more
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Real-world evidence of allergen immunotherapy
Current Opinion in Allergy & Clinical ImmunologyPurpose of review The full understanding of the long-term effectiveness and safety of allergen immunotherapy (AIT) for allergic respiratory diseases cannot be achieved through randomized controlled trials (RCTs) alone.
Buta, Federica +5 more
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Using real-world evidence in haematology
Best Practice & Research Clinical HaematologyMost new drug approvals are based on data from large randomized clinical trials (RCTs). However, there are sometimes contradictory conclusions from seemingly similar trials and generalizability of conclusions from these trials is limited. These considerations explain, in part, the gap between conclusions from data of RCTs and those from registries ...
Passamonti, Francesco +6 more
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Whitepaper: Real World Evidence
Als Real World Evidence (RWE) bezeichnet man die gewonnenen medizinischen Erkenntnisse, die aus Beobachtungsstudien und der Darstellung der Versorgungsrealität mit Massendatenquellen (Big Data) gewonnen werden (Behrendt 2019). Sie erlauben im Gegensatz zu randomisierten klinischen Studien häufig eine höhere Generalisierbarkeit (externe Validität ...Manuel Heurich, Anne Demond
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[All evidence is real world evidence.]
Recenti progressi in medicina, 2020Randomized controlled trials are criticized for the difficulty of translating the results obtained to healthcare and clinical practice. The populations of patients enrolled in the studies are supposed to be too different from the patients encountered daily by the health professionals.
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Randomization versus Real-World Evidence
New England Journal of Medicine, 2020Almut G, Winterstein +2 more
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