Blog
RSS FeedPosted by Michael Wonder on 05 May 2020
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. ...
Posted by Michael Wonder on 04 May 2020
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 ...
Posted by Michael Wonder on 23 Apr 2020
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 ...
Posted by Michael Wonder on 20 Apr 2020
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 ...
Posted by Michael Wonder on 18 Apr 2020
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). ...
Posted by Michael Wonder on 16 Apr 2020
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 ...
Posted by Michael Wonder on 30 Mar 2020
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 ...
Posted by Michael Wonder on 26 Mar 2020
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 ...
Posted by Michael Wonder on 25 Mar 2020
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 ...
Posted by Michael Wonder on 25 Mar 2020
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 ...
Posted by Michael Wonder on 18 Mar 2020
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 ...
Posted by Michael Wonder on 04 Mar 2020
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. ...
Posted by Michael Wonder on 18 Feb 2020
Paying clinical trial participants: legal risks and mitigation strategies
18 February 2020 - Offering remuneration to participants in cancer trials can promote recruitment and retention. ...
Posted by Michael Wonder on 18 Feb 2020
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, ...
Posted by Michael Wonder on 16 Feb 2020
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 ...