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Real-world evidence

Recenti Progressi in Medicina, 2017
Le evidenze derivate dal mondo reale, basate su database elettronici sanitari, registri di malattia o di prodotto e studi osservazionali, sono fra i temi più discussi nell’ambito dei congressi medici. Al fine di facilitare l’approvazione di nuove terapie e di nuovi dispositivi, le evidenze dal mondo reale si rivelano un utile strumento a supporto dei ...
Luca, De Fiore, Antonio, Addis
openaire   +2 more sources

Real-World Evidence in the Real World: Beyond the FDA

American Journal of Law & Medicine, 2018
The 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 in pediatrics

Pediatric Allergy and Immunology
non ...
Mattia Giovannini   +14 more
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Real-world evidence of allergen immunotherapy

Current Opinion in Allergy & Clinical Immunology
Purpose 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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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
openaire   +1 more source

Real-world Evidence Simplified for Clinicians

Journal of The Association of Physicians of India
Real-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
openaire   +2 more sources

Raising the Impact of Real World Evidence

2019
In an environment in which most regulatory and authoritative health strategy decisions are made on the basis of randomised control trials, real-world evidence (RWE), primarily derived from electronic health records, remains a second-class citizen. Real world evidence is widely taken to include Pragmatic clinical trials and insights derived from the ...
openaire   +2 more sources

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