Health Canada begins release of clinical data on drugs and devices

14 March 2019 - Health Canada launched two public databases on Wednesday as the first step in making clinical information ...

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Statement by FDA Commissioner on new strategies to modernise clinical trials to advance precision medicine, patient protections and more efficient product development

14 March 2019 - Modernizing clinical trials is an agency wide priority.  ...

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Marginal effects—quantifying the effect of changes in risk factors in logistic regression models

8 March 2019 - Marginal effects can be used to express how the predicted probability of a binary outcome changes ...

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Cluster randomised trials

4 March 2019 - Cluster randomised trials randomise groups of individuals rather than individuals themselves to interventions.  ...

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Treatment effects in multi-centre randomised clinical trials

1 March 2019 - It is common for treatments to be evaluated in clinical trials that involve many sites or centres, ...

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Under representation of elderly in clinical trials: an analysis of the initial approval documents in the FDA database

25 February 2019 - A cross‐sectional, structured review of publicly available initial approval documents of FDA approved drugs was performed.  ...

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Modernising clinical trials for patients with cancer

23 January 2019 - Clinical trials involve evaluating and validating new therapies in humans and represent the fundamental means of making ...

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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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Lilly reports results of Phase 3 soft tissue sarcoma study of Lartruvo

18 January 2019 - Lartruvo in combination with doxorubicin previously showed an overall survival benefit in soft tissue sarcoma in a ...

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FDA is urged to mandate disclosure of clinical trial summaries as pilot program stalls

16 January 2019 - One year after the FDA launched a voluntary pilot program to release clinical study reports, which ...

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Sweet smell of success for patients taking the sugar pill

15 January 2019 - A placebo is anything that seems to offer a real medical treatment, but doesn’t. It could ...

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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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Metastasis-free survival in prostate cancer: faster drug approvals, better drugs?

12 December 2018 - On 13 February 2018, the US FDA granted marketing authorisation to apalutamide for treatment of non-metastatic castration-resistant ...

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Australia's first telehealth cancer drug trial

3 December 2018 - A partnership between north Queensland hospitals is bringing potentially life-saving cancer drug trials to rural patients. ...

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