When are RCTs required for breakthrough drugs, HDEs? JAMA study investigates

11 September 2019 - A new study in JAMA Network Open finds that drugs and medical devices approved by the ...

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Who’s missing from breast cancer trials? Men, says the FDA

9 September 2019 - Men do get breast cancer, but they account for fewer than 1 percent of patients and often ...

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Clinical trials to combat reproductive cancers

9 September 2019 - The Australian Government is investing up to $15 million in targeted clinical trials to improve treatments and ...

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FDA urges inclusion of men in breast cancer clinical trials

28 August 2019 - Men with breast cancer make up less than one percent of all breast cancer cases, but ...

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Placebos and blinding in randomised controlled cancer clinical trials for drug and biological products: guidance for industry

28 August 2019 - This guidance provides recommendations to industry about the use of placebos and blinding in randomised controlled clinical ...

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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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In praise of studies that use more than one generic preference-based measure

12 July 2019 - Generic preference-based measures of health-related quality of life are widely used as outcome measures in cost-effectiveness and ...

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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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Call for all sponsors to publish clinical trial results in EU database

3 July 2019 - The European Commission, the European Medicines Agency and the Heads of Medicines Agencies have co-signed a ...

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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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Sask. Cancer Agency started chemotherapy drug trial without required Health Canada approval

11 June 2019 - Agency says it 'proactively' paused trial 5 months after it started. ...

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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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