Randomised, controlled trials in health insurance systems

6 September 2017 - The well-recognised limitations of traditional randomised, controlled trials, including their cost, the nature of the patients and ...

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Statistical and clinical significance

4 September 2017 - In published research, a statistically significant result is often wrongly interpreted as representing a clinically important ...

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Major new measures to help combat rare cancers

24 August 2017 - The Australian Government is supporting major new initiatives that will improve access to clinical trials, particularly for ...

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What should patients be told about non-inferiority studies?

21 August 2017 - A non-inferiority trial is a study in which a new treatment is compared with an existing, already ...

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A cancer conundrum: too many drug trials, too few patients

12 August 2017 - With the arrival of two revolutionary treatment strategies, immunotherapy and personalised medicine, cancer researchers have found ...

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Evidence for health decision making — beyond randomised, controlled trials

2 August 2017 - A core principle of good public health practice is to base all policy decisions on the highest-quality ...

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Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study

26 July 2017 - Goldacre et al. set out to identify the policies of major pharmaceutical companies on transparency of trials, ...

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Revised guideline on first-in-human clinical trials

25 July 2017 - Guidance outlines strategies to identify and mitigate risks for trial participants. ...

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Tackling submission and publication bias

17 July 2017 - Evoniuk and colleagues analysed whether submission and publication bias are based on study outcome. ...

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Multidimensional evidence generation and FDA regulatory decision making defining and using “real-world” data

13 July 2017 - Evidence linking interventions with health outcomes is the basis for good health care decision making.  ...

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FDA collaborates to promote safety, quality in clinical trials done in India

12 July 2017 - After more than 16 hours of travel, we touch down in Mumbai late in the evening ...

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Clinical trials provide $1.1b to Australian economy: MTPConnect releases report on clinical trials ecosystem in Australia

21 June 2017 - MTPConnect today released a new report ‘Clinical Trials in Australia: the economic profile and competitive position ...

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Emerging use of early health technology assessment in medical product development: a scoping review of the literature

20 June 2017 - Early health technology assessment is increasingly being used to support health economic evidence development during early stages ...

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Regulators in EU, Japan and US take steps to facilitate development of new antibiotics

12 June 2017 - EMA, PMDA and FDA align data requirements and agree on areas of convergence. ...

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Workshop: addressing unmet needs of children with pulmonary arterial hypertension

6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...

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