Blog
RSS FeedPosted by Michael Wonder on 28 Apr 2021
FDA takes action for failure to submit required clinical trial results information to ClinicalTrials.gov
28 April 2021 - Being transparent about the results of completed clinical trials enables important advances in the development of medical ...
Posted by Michael Wonder on 26 Nov 2020
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 ...
Posted by Michael Wonder on 11 Nov 2020
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 ...
Posted by Michael Wonder on 12 Oct 2020
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 ...
Posted by Michael Wonder on 24 Aug 2020
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 ...
Posted by Michael Wonder on 18 Aug 2020
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 ...
Posted by Michael Wonder on 17 Aug 2020
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 ...
Posted by Michael Wonder on 03 Aug 2020
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. ...
Posted by Michael Wonder on 31 Jul 2020
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 ...
Posted by Michael Wonder on 20 Jul 2020
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. ...
Posted by Michael Wonder on 15 Jul 2020
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. ...
Posted by Michael Wonder on 12 Jul 2020
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. ...
Posted by Michael Wonder on 18 Jun 2020
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 ...
Posted by Michael Wonder on 04 Jun 2020
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 ...
Posted by Michael Wonder on 25 May 2020
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 ...