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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Direct or indirect comparison: reliance on innovative drug data key to engaging data protection

15 August 2020 - The Federal Court recently issued its decision in Natco v Canada (Minister of Health), 2020 FC 788, ...

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Characteristics and strength of evidence of COVID-19 studies registered on ClinicalTrials.gov

27 July 2020 - The coronavirus disease 2019 (COVID-19) pandemic has led to a massive activation of clinical research.  ...

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Weighing the benefits and risks of proliferating observational treatment assessments: observational cacophony, randomised harmony

31 July 2020 - Amid the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, substantial effort is being directed toward ...

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Global regulatory workshop on COVID-19 real-world evidence and observational studies

31 July 2020 - Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main ...

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Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable outcomes for clinical trials

31 July 2020 - International regulators have published a report today on the acceptability of various primary outcomes in the ...

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Trials of a vaccine and new drug raise hope of beating COVID-19

20 July 2020 - The latest tests with Oxford University’s vaccine, and interferon beta, look promising. ...

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Improving clinical trial enrollment — In the COVID-19 era and beyond

15 July 2020 - More than 3 million people in the United States are known to have been infected with SARS-CoV-2.  ...

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COVID-19 is forcing us to rethink clinical trials for cancer treatments

9 July 2020 - Participation rates were already low, but the pandemic threatens to drive them even lower. ...

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Australian vaccine trial starts today

13 July 2020 - Australian scientists are on track to deliver a COVID-19 vaccine this year, with the start on Monday ...

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