FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty

27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...

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Regulatory harmonisation of clinical trials in the EU: clinical trials regulation to enter into application and new clinical trials information system to be launched

25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment and ...

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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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Biased Outcome reporting Guidelines for Underwhelming Studies (BOGUS) statement and checklist

10 December 2021 - A light hearted article to end the year. Merry Christmas to all our readers. We will ...

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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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Call for a central portal for clinical study reports

1 December 2021 - In an open-access publication in the Journal of European CME, two authors from IQWiG argue that ...

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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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Representativeness of participants eligible to be enrolled in clinical trials of aducanumab for Alzheimer disease compared with Medicare beneficiaries with Alzheimer disease and mild cognitive impairment

9 September 2021 - In June 2021, the US FDA granted accelerated approval for aducanumab to treat patients with mild cognitive ...

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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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