Blog
RSS FeedPosted by Michael Wonder on 19 May 2021
FDA launches crowdsourcing challenge to solicit input on research questions to be addressed through FDA's oncologic clinical trial data
18 May 2021 - Today, the U.S. FDA's Oncology Center of Excellence launched the “Send Your Oncology Research Questions to ...
Posted by Michael Wonder on 19 May 2021
FDA: flexibility okay for gaps in gene therapy trials
18 May 2021 - The US FDA is not amenable to changing study outcome measures or sample sizes for gene therapy ...
Posted by Michael Wonder on 12 May 2021
Public availability of results of ClinicalTrials.gov registered expanded access studies
10 May 2021 - Expanded access is the use of investigational treatments outside of clinical trials. Results of expanded access studies ...
Posted by Michael Wonder on 07 May 2021
International regulators and WHO call for wider public access to clinical data
7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...
Posted 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 21 Apr 2021
Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
21 April 2021 - EMA’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables ...
Posted by Michael Wonder on 22 Feb 2021
Clinical relevance of patient-reported outcomes: new threshold proves to be practical
18 February 2021 - Current examples show that the 15% threshold newly set by IQWiG for the recognition of responder analyses ...
Posted by Michael Wonder on 04 Feb 2021
Coronavirus: mix and match vaccine trial amid shortage fears
4 February 2021 - Britain has begun the world’s first trial to explore “mixing and matching” vaccines in the hope ...
Posted by Michael Wonder on 14 Dec 2020
From publication bias to lost in information
11 December 2020 - In BMJ Evidence-Based Medicine, IQWiG researchers call for a central, public and worldwide portal for clinical ...
Posted by Michael Wonder on 11 Dec 2020
CSL, University of Queensland coronavirus vaccine trials halted
11 December 2020 - CSL and University of Queensland researchers knew of the potential for false HIV positives in the ...
Posted by Michael Wonder on 10 Dec 2020
Australian COVID vaccine terminated due to HIV ‘false positives’
11 December 2020 - A billion-dollar deal for the Morrison government to buy more than 50 million doses of the ...
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 25 Nov 2020
Medical trial delays see Australians wait for rare disease treatment
25 November 2020 - Patients with rare diseases are entering ‘random lottery’ draws for clinical trials because Australia is too slow ...
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 06 Nov 2020
Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme
6 November 2020 - The TGA has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical ...