Global regulators discuss observational studies of real world data for COVID-19 medicines

7 April 2020 - In a dedicated COVID-19 workshop, organised by the EMA under the umbrella of the International Coalition of ...

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Expanded access as a source of real‐world data: an overview of FDA and EMA approvals

22 March 2020 - The authors set out to identify, characterise, and compare all FDA and EMA approvals that included real‐world ...

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FDA announces funding opportunity to explore the use of real-world data to generate real-world evidence in regulatory decision making

25 March 2020 - The U.S. Food and Drug Administration is announcing a funding opportunity for projects to support the ...

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Drug pricing review group signs deal with Aetion for patient data

24 February 2020 - The Institute for Clinical and Economic Review (ICER), a small but influential Boston-based research group, has ...

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ICER and Aetion partner to develop real-world evidence for value assessment of treatments

24 February 2020 - ICER adopts Aetion’s Real-World Evidence Platform — advancing standards for the use of transparent, replicable real-world ...

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Real world evidence - from safety to a potential tool for advancing innovative ways to develop new medical therapies

24 February 2020 - Real world evidence has the potential to enhance the efficiency of drug development and provide new evidence ...

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RWE: cost and time savings entice sponsors as pitfalls linger

14 February 2020 - The New England Journal of Medicine published an article earlier this week raising questions about the ...

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The magic of randomisation versus the myth of real world evidence

12 February 2020 - Non-randomised observational analyses have been promoted as alternatives to randomised clinical trials.  ...

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Basket cases: how real-world testing for drugs approved based on basket trials might lead to false diagnoses, patient risks, and squandered resources

14 January 2020 - Basket trials, studies designed to assess the safety and efficacy of therapeutics targeted to a specific molecular ...

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FDA real world evidence to be made available on Google Cloud

8 January 2020 - The company is making the agency's open-source MyStudies platform available, enabling for easier access to data for ...

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RWE to supplement RCTs: FDA projects continue

15 October 2019 - The US FDA has been working with several different data and research companies to further its ...

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Harnessing the patient voice in real world evidence: the essential role of patient-reported outcomes

30 September 2019 - Real-world evidence is increasingly valued by regulators and payers.  ...

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FDA announces a new Sentinel System contract, affirming its commitment to harnessing real-world data to improve the safety and effectiveness of drugs

27 September 2019 - Today, the U.S. FDA is announcing an award granting a new five-year contract for the Sentinel ...

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Accelerating the shift toward person-generated real world evidence

19 September 2019 - Evidence generated from randomised clinical trials and other clinical studies has long been the foundation for ...

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FDA developing guidance on real world data quality issues, officials say

9 September 2019 - As the US FDA grapples with how to use real-world data for regulatory decisions, two FDA ...

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