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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Re-evaluating eligibility criteria for oncology clinical trials: analysis of investigational new drug applications in 2015

22 November 2017 - Clinical trial eligibility criteria are necessary to define the patient population under study and improve trial safety.  ...

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Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement

22 November 2017 - Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardise the generalisability of results, and limit ...

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Mendelian randomisation

21 November 2017 - Mendelian randomisation uses genetic variants to determine whether an observational association between a risk factor and an ...

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The “utility” in composite outcome measures

14 November 2017 - Measuring what is important to patients. ...

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Nearly half of recent EU approvals based on a single pivotal study

10 November 2017 - A recent study found that 45% of marketing authorizations granted in the EU from 2012 to ...

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Cancer drug study data was falsified, says AstraZeneca

14 October 2017 - An early lab study supporting a cancer drug bought by British drugmaker AstraZeneca was falsified, the ...

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Gatekeeping strategies for avoiding false-positive results in clinical trials with many comparisons

10 October 2017 - Clinical trials characterizing the effects of an experimental therapy rarely have only a single outcome of interest. ...

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Cheaper drug trials would lower prices: FDA chief

15 September 2017 - Decreasing the time and cost it takes to develop a drug would lower drug prices, FDA ...

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