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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Statement on data accuracy issues with recently approved gene therapy

6 August 2019 - As a public health agency, we believe that it is critical to facilitate the development of ...

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Surrogate endpoints in randomised controlled trials: a reality check

27 July 2019 - At the 24th Congress of the European Hematology Association in June, 2019, the results of the BELLINI ...

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European Medicines Agency is advised to take steps to avoid bias concerns over approvals

22 July 2019 - Following a two-year inquiry, the European Ombudsman has recommended the European Medicines Agency take several steps ...

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Using instrumental variables to address bias from unobserved confounders

2 May 2019 - Randomised clinical trials are considered the most reliable source of evidence for the effects of medical interventions, ...

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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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Patient experience data and bias — what ratings don’t tell us

28 February 2018 - Although patient-experience data are important to U.S. health care organisations, the best way to interpret them remains ...

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Using the E value to assess the potential effect of unmeasured confounding in observational studies

24 January 2019 - Randomised trials serve as the standard for comparative studies of treatment effects.  ...

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Random-effects meta-analysis: summarising evidence with caveats

22 January 2019 - Questions involving medical therapies are often studied more than once. For example, numerous clinical trials have been ...

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Patient groups fail to declare financial interests during NICE assessments

16 January 2019 - Patients’ groups involved in assessing treatments for the NHS often fail to disclose their financial interests, ...

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Challenges of non-intention-to-treat analyses

15 January 2019 - Over the past 5 decades, the randomised clinical trial has become the gold standard for evaluation ...

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Establishing the effectiveness of procedural interventions: the limited role of randomised trials

18 December 2018 - Procedural interventions comprise a large and growing component of medical care. Patients, physicians, health care organisations, and ...

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Bayesian hierarchical models

11 December 2018 - Treatment effects will differ from one study to another evaluating similar therapies, both because of random variation ...

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Choice of control group in randomised trials of cancer medicine: are we testing trivialities?

31 August 2018 - Several trials in cancer medicine over the past 5 years share two common features: first, they were ...

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Pfizer calls for FDA guidance to address false and misleading biosimilar advertisements

28 August 2018 - Taking issue with Amgen, Genentech and other reference product sponsors’ dissemination of misleading information on biosimilars, ...

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