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15 July 2019 - Just over two months ago, the US FDA released draft guidance explaining to drugmakers what constitutes ...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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Attempt to replicate clinical trials with real world data generates real world criticism, too

3 July 2019 - It’s one of the most seductive ideas in medicine: that “real-world evidence,” including data from electronic ...

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NICE explores extending its use of data to inform its guidance

25 June 2019 - NICE has revised its earlier press release on the use of real world data to inform ...

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Real world evidence: the future is here

26 June 2019 - Use of real-world evidence is becoming increasingly common to aid the clinical development process and provide ...

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NICE explores extending its use of real world data to inform its guidance

25 June 2019 - NICE is looking to extend the use of real world data that will help inform its ...

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Do cancer treatments have option value? Real‐world evidence from metastatic melanoma

24 June 2019 - A change in the expectations about future treatments may change the option value of a current ...

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How to deal with the inevitable: generating real-world data and using real-world evidence for HTA purposes – from theory to action

14 June 2019 - Real-world evidence, derived from real-world data, is already used, to some extent, for health technology assessment purposes.  ...

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Use of real world data sources for Canadian drug pricing and reimbursement decisions: stakeholder views and lessons for other countries

29 May 2019 - Canada has a long history of the use of clinical evidence to support health care decision making.  ...

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FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications

8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...

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FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials

10 April 2019 - Can real-world evidence substitute for a clinical drug trial that meets the full gold standard on data? ...

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The evolving uses of “real world” data

9 April 2019 - The terms real world data and real-world evidence have entered the medical lexicon to refer to ...

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Effectiveness in the absence of efficacy: cautionary tales from real world evidence

21 March 2019 - Real-world data are collected outside of traditional clinical trials and may include electronic health records, patient registries, ...

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