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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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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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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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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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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Public availability of results of ClinicalTrials.gov registered expanded access studies

10 May 2021 - Expanded access is the use of investigational treatments outside of clinical trials. Results of expanded access studies ...

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