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15 July 2019 - Just over two months ago, the US FDA released draft guidance explaining to drugmakers what constitutes ...

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Academies call on health minsters to resolve health data issues

15 July 2019 - Regulatory barriers that limit timely access to population and health data must be resolved to achieve ...

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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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Use real world data, not international reference pricing to set US drug prices

25 June 2019 - The Trump administration has proposed using international reference pricing for medicines.  ...

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Two words to help Ned Sharpless revolutionise clinical trials: data standards

13 May 2019 - In the classic 1967 film “The Graduate,” young Benjamin Braddock was given one word of advice ...

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Rx drug costs: list prices versus net prices and the importance of staying within the data

13 March 2019 - The authors of a recent Health Affairs article asked a meaningful question: Are new drugs or ...

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Patient experience data and bias — what ratings don’t tell us

28 February 2018 - Although patient-experience data are important to U.S. health care organisations, the best way to interpret them remains ...

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My Health Record opt-out doubles to 2.5 million people

20 February 2019 - The number of Australians who opted out of the My Health Record system doubled after the ...

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Big opportunities in big data, but EMA and industry just getting started

18 February 2019 - 250m genomes sequenced, but data trapped in silos. ...

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My Health Record reflects 'new consensus', says CEO Tim Kelsey

19 February 2019 - The government's controversial My Health Record was part of a "new consensus" on digital health, said ...

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Role of big data for evaluation and supervision of medicines in the EU

15 February 2019 - Recommendations for a path towards understanding the acceptability of evidence derived from ‘Big data’ in support ...

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Number needed to treat: conveying the likelihood of a therapeutic effect

7 February 2019 - Effectively communicating clinical trial results to patients and clinicians is a requirement for appropriate application in ...

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Comparing PHARMAC's outcomes with those of Australia

7 February 2019 - New Zealand's Prime Minister Jacinda Ahern's claim that is unfair to compare PHARMAC's outcomes with those ...

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My Health Record enshrines choice

24 January 2019 - A change in the law enabling people to delete permanently their My Health Record, should strengthen ...

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