Clinical relevance of patient-reported outcomes: new threshold proves to be practical

18 February 2021 - Current examples show that the 15% threshold newly set by IQWiG for the recognition of responder analyses ...

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Coronavirus: mix and match vaccine trial amid shortage fears

4 February 2021 - Britain has begun the world’s first trial to explore “mixing and matching” vaccines in the hope ...

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From publication bias to lost in information

11 December 2020 - In BMJ Evidence-Based Medicine, IQWiG researchers call for a central, public and worldwide portal for clinical ...

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CSL, University of Queensland coronavirus vaccine trials halted

11 December 2020 - CSL and University of Queensland researchers knew of the potential for false HIV positives in the ...

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Australian COVID vaccine terminated due to HIV ‘false positives’

11 December 2020 - A billion-dollar deal for the Morrison government to buy more than 50 million doses of the ...

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After admitting mistake, AstraZeneca faces difficult questions about its vaccine

25 November 2020 - Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures ...

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Medical trial delays see Australians wait for rare disease treatment

25 November 2020 - Patients with rare diseases are entering ‘random lottery’ draws for clinical trials because Australia is too slow ...

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FDA offers guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development

9 November 2020 - To further promote and protect public health, it is important that people who are in clinical trials ...

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Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme

6 November 2020 - The TGA has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical ...

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Strengthening global collaboration on COVID-19 real-world evidence and observational studies

23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...

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Efficacy trials cost more, take longer for biosimilars than originators

11 October 2020 - Average clinical efficacy testing cost millions of dollars more for Phase 3 biosimilar studies than for ...

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CSL confirms UQ vaccine production, trials set for December

8 October 2020 - CSL says it is talking with partner organisations to help roll out doses of the University ...

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FDA may fine clinical trial sponsors that don’t report data

24 August 2020 - The US FDA has said it will penalise sponsors of clinical trials that do not report ...

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FDA finalises penalties for clinical trial sponsors that don’t share data, but critics say they fall short

18 August 2020 - After a year of deliberation, the FDA released final guidelines for penalising clinical trial sponsors that ...

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Clinical trials of coronavirus drugs are taking longer than expected

14 August 2020 - Antibody trials sponsored by Regeneron and Eli Lilly are off to a slow start because of a ...

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