001 FAD COVID 19 June 2020

FDA COVID-19: new real-world evidence data collection

FDA search for evidence based insights from health records for COVID-19 Aetion applies big-data analytics to patients’ electronic health records to evaluate safety and effectiveness for pharmaceutical and biotech companies Real-world data collection from multiple sources The rapid analytics are expected to help FDA better evaluate proposed diagnostics, vaccines, and treatments as the pandemic continues to […]

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001 DC June 2020

Real-world data to combat COVID-19

Monitoring data on hospitals’ utilisation and capacity rates: location and number of licensed beds, staffed beds, ICU beds, and total bed utilisation rates Plan for critical care based on epidemiological data on COVID-19 and clinical outcomes: modelling tools development to identify surges in clinical demand, as well as best- and worst-case scenarios of COVID-19-induced strain on […]

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001 LN Jun 2020

Real-world data is an invaluable supplement to randomised control trials

An article was published recently in the Journal of Clinical Pathways, titled “Real-World Data Will Continue to Provide Real Value to the Drug Development and Commercialization Process” It affirmed that while randomised controlled trials provide the necessary information on drug safety and efficacy, they are often not generalisable to the real-world population; but real-world information […]

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