Determining the comparative value of pharmaceutical risk-sharing policies in non–small cell lung cancer using real-world data

2 March 2019 - Risk-sharing arrangements can be used to mitigate uncertainty about the value of a drug by sharing the ...

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Industry lauds FDA RWE framework, calls for tweaks

12 February 2019 - The US FDA regulatory framework for the use of real-world evidence drew positive reactions from biopharma ...

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Statement from FDA Commissioner on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics

6 December 2018 - The health care system is integrating more effective ways to leverage electronic tools to gather and use ...

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FDA releases real-world data collection app

7 November 2018 - FDA released on Tuesday an open source code app that can be used to collect real-world ...

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Harnessing the potential of real world data through a ‘learning health care system'

28 September 2018 - Real world data hold the promise to substantially increase the effectiveness and efficiency of all processes ...

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The FDA announces Patient Engagement Advisory Committee meeting on utilising real world data from patient-driven platforms that connect and empower patients

21 September 2018 - On 15 November 2018, the FDA’s Patient Engagement Advisory Committee will hold its second public meeting ...

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Case-control studies: using “real world” evidence to assess association

23 August 2018 - Associations between patient characteristics or treatments received and clinical outcomes are often first described using observational data, ...

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Five predictions for AI and real world data in oncology

14 August 2018 - As progress in oncology care is advancing faster than ever -- especially due to the work ...

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Real world evidence and real world data for evaluating drug safety and effectiveness

13 August 2018 - For hundreds of years, the development of new medical treatments relied on “real-world” experience.  ...

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PhRMA statement on efforts to support real world evidence

12 July 2018 - PhRMA spokesperson Andrew Powaleny issued the following statement on comments made by U.S. FDA Commissioner Scott Gottlieb. ...

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FDA budget matters: a cross-cutting data enterprise for real world evidence

10 July 2018 - Over time, as our experience with new medical products expands, our knowledge about how best to maximise ...

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PBAC rejects first submission supported by real-world evidence

4 July 2018 - A retrospective chart review of 211 Australian patients with chronic migraine served as the key evidentiary basis ...

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Deloitte survey finds biopharma companies are accelerating adoption of real-world evidence

28 June 2018 - A recent survey shows that 90% of biopharma companies are making significant investments in real-world evidence ...

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ICER publishes guidance on improving the development and use of real world evidence for drug coverage and formulary decisions

10 April 2018 - The ICER, in collaboration with the Office of Health Economics, has released two new white papers to ...

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Using real world data in health technology assessment (HTA) practice: a comparative study of five HTA agencies

21 March 2018 - This study examines whether real world data is incorporated in health technology assessment (HTA) of melanoma drugs ...

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