Harms from uninformative clinical trials

25 July 2019 - Individuals who enroll in clinical trials do so with the belief that their participation will help ...

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Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices

21 July 2019 - The objective was to develop and pilot a tool to measure and improve pharmaceutical companies’ clinical trial ...

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The fragility of phase 3 trials supporting FDA approved anti-cancer medicines: a retrospective analysis

8 July 2019 - The fragility index of trial results—ie, the minimum number of changes from non-events to events resulting in ...

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Attempt to replicate clinical trials with real world data generates real world criticism, too

3 July 2019 - It’s one of the most seductive ideas in medicine: that “real-world evidence,” including data from electronic ...

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Incorporating patient preferences in non-inferiority trials

24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...

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FDA's Woodcock defends accelerated approvals and talks of culture shift in clinical trials

5 June 2019 - Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the ...

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Google sister company Verily is teaming with big pharma on clinical trials

21 May 2019 - Pharma companies are looking to work with Verily, which is part of the Alphabet umbrella, as they ...

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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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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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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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