Blog
RSS FeedPosted by Michael Wonder on 08 Oct 2020
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 ...
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 31 Jul 2020
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 ...
Posted by Michael Wonder on 31 Jul 2020
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 ...
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 12 Jul 2020
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 ...
Posted by Michael Wonder on 09 Jul 2020
International regulators align positions on phase 3 COVID-19 vaccine trials
9 July 2020 - Medicines regulatory authorities from around the world have published a report today highlighting the outcomes ...
Posted by Michael Wonder on 01 Jul 2020
International regulators provide guiding principles for COVID-19 clinical trials
1 July 2020 - EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International ...
Posted by Michael Wonder on 01 Jul 2020
Medicines Australia welcomes support for national harmonisation of clinical trials
30 June 2020 - Medicines Australia welcomes the announcement from the Minister for Health, the Hon Greg Hunt MP, during ...