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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Releasing the potential of real world evidence

4 September 2019 - Janssen believes RWE could realise an efficient, personalised and truly patient-centric health care system. ...

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Developing real-world data and evidence to support regulatory decision-making

26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, ...

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Former FDA Commissioners seek to expand use of RWE in regulatory, payment decisions

21 August 2019 - A new report from the Bipartisan Policy Center makes recommendations to expand the use of real-world ...

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Syapse announces research collaboration with the FDA focused on the regulatory use of real-world evidence

14 August 2019 - Collaboration will advance the derivation of real-world oncology endpoints and provide insights into the use of real-world ...

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The evolution of real world studies

9 August 2019 - The use of real-world evidence is evolving quickly. ...

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Australian study evaluates real world evidence of Botox to prevent migraine

26 July 2019 - OnabotulinumtoxinA has been approved by Australia’s reimbursement mechanism for medicines, the PBS, for preventive treatment of ...

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Patient registries may prove valuable in regulatory decisions, EMA study finds

18 July 2019 - Although patient registries can be heterogenous in their quality and design, a new study in Drug ...

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Gilead and Novartis seek to expand what FDA considers as real-world data and real-world evidence

15 July 2019 - Just over two months ago, the US FDA released draft guidance explaining to drugmakers what constitutes ...

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Report on the current status of the use of real‐world data and real‐world evidence in drug development and regulation

10 July 2019 - Radically expanding use of real‐world data and real‐world evidence holds the potential to substantially impact drug development, ...

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FDA leverages private sector technology-based tools in its embrace of real world evidence

9 July 2019 - Following decades of near total reliance on randomised clinical trial data, the U.S. FDA (with a ...

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