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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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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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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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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EMA Priority Medicines scheme (PRIME): will more paying-for-performance agreements be needed due to immature data?

14 September 2018 - The EU’s centralized procedure for the authorization of a new drug is performed by the EMA.  ...

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Data enclaves for sharing information derived from clinical and administrative data

28 August 2018 - The promise that big data will transform health care has yet to be fulfilled.  ...

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Tech giants pledge to ease patient, provider access to health data

13 August 2018 - Promise seen as opportunity to bring on data-driven revolution in health care. ...

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IBM bet billions that Watson could improve cancer treatment. It hasn’t worked.

11 August 2018 - Big Blue’s Watson artificial intelligence product sometimes didn’t say more than doctors already knew. ...

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EMA’s proactive publication of clinical data a success

16 July 2018 - First report on unprecedented transparency policy shows high user satisfaction. ...

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Health Canada ordered to release confidential drug company data on HPV vaccines

13 July 2018 - Federal government insisted drug companies' clinical trial data is 'confidential business information'. ...

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Gottlieb calls on payers to share data to aid drug innovation

25 June 2018 - The FDA is working to modernize the clinical trial process in order to answer the right ...

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Clinical trial participants’ views of the risks and benefits of data sharing

7 June 2018 - Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants ...

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Understanding statistical principles in linear and logistic regression

7 May 2018 - A previous article in this series assessed the association between two variables. Here, we introduce the concept ...

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Post-marketing modifications of drug labels for cancer drugs approved by the US FDA between 2006 and 2016 with and without supporting randomized controlled trials

11 April 2018 - Modifications in cancer drug indications, dosing, and related toxicities after FDA approval are common. It is unclear ...

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