Beyond survival: the US FDA confirms surrogate end points for patients with newly diagnosed acute myeloid leukaemia treated with intensive chemotherapy

10 January 2022 - The treatment of acute myeloid leukaemia has rapidly evolved over the past decade.  ...

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Accelerating clinical trials in the EU: for better clinical trials that address patients’ need

13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...

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Improvements to clinical trials will strengthen Australia’s economy and benefit patients

8 December 2021 - Clinical trials in Australia need improvements if we are to increase our global competitiveness says Medicines ...

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Use of confidence intervals in interpreting non-statistically significant results

23 November 2021 - The goal of much of medical research is to determine which of 2 or more therapeutic approaches ...

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Strengthening the FDA’s enforcement of ClinicalTrials.gov reporting requirements

12 November 2021 - On 28 April 2021, the US FDA announced that it “issued its first Notice of Non-compliance to ...

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Collecting patient reported outcomes in cancer clinical trials

3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...

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Interpreting the results of intention to treat, per protocol and as treated analyses of clinical trials

 3 August 2021 - Non-adherence in a randomised clinical trial occurs when study participants do not follow the randomly assigned treatment ...

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Working towards harmonised access to clinical trial data across European drug regulatory agencies

31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...

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Six month countdown to go live for the Clinical Trials Information System

2 August 2021 - The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and ...

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FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues

26 July 2021 - Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several ...

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Most clinical trials failed to meet U.S. transparency requirements for recently approved drugs

22 July 2021 - In the latest look at clinical trial transparency, a new analysis found that only 26% of ...

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Clinical trial national approach will benefit patients and our economy

20 July 2021 - Medicines Australia welcomes the clinical trial ‘one-stop-shop’ consultation, recently announced by the Australian Commission on Safety ...

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Rival treatments may help justify FDA gamble with Biogen Alzheimer’s drug

18 June 2021 - Data from clinical trials of three experimental Alzheimer’s disease drugs expected to start emerging next year ...

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Core patient reported outcomes in cancer clinical trials

9 June 2021 - This guidance provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes ...

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Adjusting for non-adherence or stopping treatments in randomised clinical trials

25 May 2021 - Randomised clinical trials allocate individuals to different treatments, or, more generally, to interventions and comparators, to determine ...

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