Clinical trial processes

31 March 2020 - The TGA has received a number of enquiries about processes for clinical trials relating to COVID-19 ...

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FDA guidance on conduct of clinical trials of medical products during the COVID-19 pandemic

30 March 2020 - The U.S. FDA today issued an updated guidance, “Conduct of Clinical Trials of Medical Products during ...

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COVID-19: frontline virus fighters to trial TB vaccine

27 March 2020 - Thousands of Australian doctors, nurses and health workers will be given a tuberculosis vaccine in a ...

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Preserving clinical trial integrity during the coronavirus pandemic

25 March 2020 - Randomised clinical trials provide the highest-quality evidence for identifying therapies to help people attain longer and healthier ...

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COVID-19 and angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: what is the evidence?

24 March 2020 - Coronavirus disease 2019 is a current pandemic infection caused by a positive-sense RNA virus named the severe ...

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Treating COVID-19—off-label drug use, compassionate use, and randomised clinical trials during pandemics

24 March 2020 - In the 2014 Ebola outbreak, close to 30 000 individuals developed Ebola viral disease, and numerous therapies were ...

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Global regulators map out data requirements for phase 1 COVID-19 vaccine trials

24 March 2020 - Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine ...

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Coronavirus drug to be trialled on frontline health workers

25 March 2020 - Australia is moving towards a new coronavirus preventive trial for frontline healthcare workers as the number of ...

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Rush to raise funds for large COVID-19 drug trial in Australian hospitals

23 March 2020 - Australian researchers behind a new clinical trial of two drugs to treat COVID-19 are desperate to ...

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Coronavirus (COVID-19) update: FDA issues guidance for conducting clinical trials

18 March 2020 - The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review ...

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When a drug study abruptly ends, volunteers are left to cope

3 March 2020 - A participant might commit months or years to a drug trial, only to see it vanish overnight. ...

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Paying clinical trial participants: legal risks and mitigation strategies

18 February 2020 - Offering remuneration to participants in cancer trials can promote recruitment and retention.  ...

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Randomised clinical trials of artificial intelligence

17 February 2020 - As patient data are increasingly captured digitally, the opportunities to deploy artificial intelligence, especially machine learning, ...

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RWE: cost and time savings entice sponsors as pitfalls linger

14 February 2020 - The New England Journal of Medicine published an article earlier this week raising questions about the ...

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Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study

17 January 2020 - Failure to report the results of a clinical trial can distort the evidence base for clinical practice, ...

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