Considerations in demonstrating interchangeability with a reference product guidance for industry

9 May 2019 - This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable ...

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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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Substandard control arms question the utility of some new cancer drugs

2 May 2019 - The rapid pace of new cancer drugs approved by the FDA, 16 in 2018 alone, is ...

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Labor to fast-track leukaemia drug trials

17 April 2019 - Patients with deadly blood cancers will get faster access to potentially life-saving drug trials if Labor ...

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FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials

10 April 2019 - Can real-world evidence substitute for a clinical drug trial that meets the full gold standard on data? ...

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The evolving uses of “real world” data

9 April 2019 - The terms real world data and real-world evidence have entered the medical lexicon to refer to ...

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The importance of predefined rules and pre-specified statistical analyses: do not abandon significance

4 April 2019 - For decades, statisticians and clinicians have debated the meaning of statistical and clinical significance.  ...

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The stepped wedge cluster randomised trial: what it is and when it should be used

1 April 2019 - The basic premise of a stepped wedge cluster randomised trial is that all clusters start in the ...

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Statement by FDA Commissioner, Director of FDA’s Center for Drug Evaluation and Research and Director of FDA’s Center for Biologics Evaluation and Research on expanded access–looking forward

29 March 2019 - For more than 30 years, the FDA has supported patients’ access to investigational medical products for ...

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Effectiveness in the absence of efficacy: cautionary tales from real world evidence

21 March 2019 - Real-world data are collected outside of traditional clinical trials and may include electronic health records, patient registries, ...

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Health Canada begins release of clinical data on drugs and devices

14 March 2019 - Health Canada launched two public databases on Wednesday as the first step in making clinical information ...

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Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development

14 March 2019 - Modernizing clinical trials is an agency wide priority.  ...

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Marginal effects—quantifying the effect of changes in risk factors in logistic regression models

8 March 2019 - Marginal effects can be used to express how the predicted probability of a binary outcome changes ...

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Cluster randomised trials

4 March 2019 - Cluster randomised trials randomise groups of individuals rather than individuals themselves to interventions.  ...

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Treatment effects in multi-centre randomised clinical trials

1 March 2019 - It is common for treatments to be evaluated in clinical trials that involve many sites or centres, ...

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