Are big clinical trials relevant? Researchers disagree

29 May 2018 - Amid health care tailored to an individual’s DNA, do massive clinical trials that take years and involve ...

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Key design considerations for adaptive clinical trials: a primer for clinicians

8 March 2018 - This article reviews important considerations for researchers who are designing adaptive clinical trials.  ...

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The stepped-wedge clinical trial

13 February 2018 - Evaluation by rolling deployment. ...

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Cancer research funding has an inherent bias that often excludes rare cancers, expert says

3 February 2018 - The biggest investor in cancer research in Australia needs to address an "inherent bias" in how ...

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Standard deviation and standard error: interpretation, usage and reporting

5 February 2018 - Standard deviations and standard errors are reported routinely in statistical analyses, but the distinction between them is ...

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EU proposes joint studies to speed acceptance of new medicine

31 January 2018 - The European Commission proposed on Wednesday joint clinical assessments to determine whether approved new drugs and ...

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Characteristics of interim publications of randomised clinical trials and comparison with final publications

23 January 2018 - Publication of interim results of randomised trials can be consequential, potentially undermining trial integrity by unblinding or ...

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FDA Commissioner on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs

16 January 2018 - Scientific progress and new drug innovation don’t take place in a vacuum.  ...

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Atezolizumab, pembrolizumab, nivolumab in urothelial carcinoma: studies of direct comparison are useful

4 January 2018 - Four dossier assessments involving comparisons between immunotherapies and chemotherapies for the same therapeutic indication in 2017/comparison ...

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German watchdog calls for direct comparison of cancer immunotherapies

16 January 2018 - Germany’s drug assessment body has criticized a lack of data directly comparing drugs in a promising ...

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Finding RCTs of new drugs: searches in trial registries require specific adaptations

5 January 2018 - In their article in the Journal of Clinical Epidemiology, Marco Knelangen, Elke Hausner, Sibylle Sturtz, and ...

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Many FDA approved cancer drugs might lack clinical benefit

21 December 2017 - New research shows that less than half of the randomised controlled trials that support the approval of ...

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Bringing early feasibility studies for medical devices back to the United States

12 December 2017 - Ten years ago, when medical device manufacturers wanted to gain early clinical experience with their new devices ...

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Drug makers continue to owe FDA numerous clinical trials

7 December 2017 - Under various circumstances, the FDA may require a drug maker to run a post-marketing study, but ...

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FDA required studies of approved drugs make a big difference for public health

7 December 2017 - Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be ...

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