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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The value of using registries to evaluate randomised clinical trial study populations

5 June 2017 - Randomised clinical trials are considered the gold standard of medical research and influence clinical practice, but they ...

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Prima’s trial backs safety of metastatic breast cancer drug

5 June 2017 - The Lucy Turnbull-chaired biotech Prima Biomed has revealed new data that backs the safety of its ...

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Health policy trials

31 May 2017 - Clinical trials are most commonly associated with drugs and devices, but there are notable examples of trials ...

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South Australia slashes pathology, medical science jobs

31 May 2017 - Medical unions say timely patient treatments and diagnoses could be at risk after the South Australian ...

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NICE to launch new evidence tool for medtech product developers

30 May 2017 - NICE is launching an online tool to help medtech companies get their products to patients faster. ...

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Designing clinical trials that accept new arms: an example in metastatic breast cancer

22 May 2017 - The majority of randomised oncology trials are two-arm studies that test the efficacy of new therapies against ...

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Medical research reforms to improve our future health

25 May 2017 - The Australian Government provides more than $800 million through the National Health and Medical Research Council each ...

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