Clinical trial costs to develop a new drug may actually be rather modest — or so one study suggests

18 June 2020 - For years, the pharmaceutical industry has maintained that the costs to develop medicines accounts for rising ...

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The Lancet, New England Journal retract COVID-19 studies, including one that raised safety concerns about malaria drugs

4 June 2020 - The Lancet, one of the world’s top medical journals, on Thursday retracted an influential study that ...

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WHO pauses trial of hydroxychloroquine in COVID-19 patients due to safety concerns

26 May 2020 - The World Health Organisation has suspended testing the malaria drug hydroxychloroquine in COVID-19 patients due to ...

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Pfizer and Biontech dose first participants in the U.S. as part of global COVID-19 MRNA vaccine development program

5 May 2020 - Pfizer and BioNTech ramping up manufacturing capabilities to further increase production capacity in 2020/2021. ...

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Randomised clinical trials and COVID-19: managing expectations

4 May 2020 - Despite the millions of cases and hundreds of thousands of deaths that have occurred in this devastating ...

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Increasing access to FDA inspection reports on irregularities and misconduct in clinical trials

23 April 2020 - Transparency related to clinical trial protocols and data has become the expected standard over the past 2 ...

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Novartis to sponsor large clinical trial of hydroxychloroquine in hospitalised COVID-19 patients

20 April 2020 - Novartis has reached an agreement with the US FDA to proceed with a Phase III clinical trial ...

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Finding effective treatments for COVID-19: scientific integrity and public confidence in a time of crisis

16 April 2020 - Everyone wants new treatments and vaccines to address the devastation of coronavirus disease 2019 (COVID-19). ...

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A strategy for improving U.S. health care delivery — conducting more randomised, controlled trials

16 April 2020 - Despite the prominence of randomised, controlled trials in medical research, they have rarely been used to evaluate ...

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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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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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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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