Evaluation of evidence of statistical support and corroboration of sub-group claims in randomised clinical trials

3 April 2017 - Many published randomised clinical trials make claims for subgroup differences. ...

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Emerging technology which aims to improve muscle movement is NICE’s 100th medtech innovation briefing

28 March 2017 - NICE’s advice series on new or novel healthcare technology reaches a milestone. ...

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Call for experts in anonymisation of clinical data

23 March 2017 - EMA to set up technical group in the context of the publication of clinical data ...

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Can a statistical method speed drug approvals?

13 March 2017 - Not likely, says F. Perry Wilson, MD. ...

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Health Canada aims to release secret drug records

13 March 2017 - A proposed Health Canada policy would make public currently confidential information about drugs’ safety and efficacy. ...

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Release of documents on two medicines temporarily halted

14 March 2017 - EMA’s appeals against interim measures are dismissed by Court of Justice ...

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Review of the drug trials snapshots program of the US FDA: women in cardiovascular drug trials

13 March 2017 - Over the last 20 years, there have been concerns that too few women and minorities are enrolled ...

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Statement from Health Canada on the publication of a white paper on public release of clinical information in drug submissions and medical device applications

9 March 2017 - Health Canada recognises that access to clinical information can help health researchers and practitioners, improve patient ...

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UK children with cancer could miss out on drug trials after Brexit, doctors warn

9 March 2017 - Fears youngsters could be denied access to Europe-wide tests of new medicines when Britain leaves EU amid ...

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Defining the non-inferiority margin and analysing non-inferiority: an overview

6 March 2017 - Non-inferiority trials are used to assess whether the effect of a new drug is not worse than ...

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Public-private partnership speeds investigator access to cancer drugs

28 February 2017 - A new collaboration between pharmaceutical and biotech companies and the National Cancer Institute at the National ...

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GSK ‘real world’ study offers new model for drug trials

27 February 2017 - Pharma groups look to evidence in normal medical settings to prove value for money. ...

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The European Medicines Agency and publication of clinical study reports: a challenge for the US FDA

20 February 2017 - The US FDA has been the standard of drug regulation worldwide for decades.  ...

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Big pharma funding biases drug trials in favour of a sponsor's product: review

21 February 2017 - Drug and device trial studies that are sponsored by the pharmaceutical industry are more likely to ...

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FDA drug trials snapshots and diversity when testing new drugs

13 February 2017 - Did you know that some drugs affect men and women differently?  ...

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