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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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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MHRA releases guidance in collaboration with Health Canada to improve patient safety in clinical trials through improving the quality of Development Safety Update Reports

6 July 2021 - The Medicines and Healthcare products Regulatory Agency and Health Canada have published guidance to improve the 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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Adjusting for covariates in randomised clinical trials for drugs and biological products

20 May 2021 - This guidance represents FDA’s current thinking on adjusting for covariates in the statistical analysis of randomised clinical ...

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FDA launches crowdsourcing challenge to solicit input on research questions to be addressed through FDA's oncologic clinical trial data

18 May 2021 - Today, the U.S. FDA's Oncology Center of Excellence launched the “Send Your Oncology Research Questions to ...

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FDA: flexibility okay for gaps in gene therapy trials

18 May 2021 - The US FDA is not amenable to changing study outcome measures or sample sizes for gene therapy ...

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