Blog
RSS FeedPosted by Michael Wonder on 23 Jul 2021
Most clinical trials failed to meet U.S. transparency requirements for recently approved drugs
22 July 2021 - In the latest look at clinical trial transparency, a new analysis found that only 26% of ...
Posted by Michael Wonder on 18 Jun 2021
Rival treatments may help justify FDA gamble with Biogen Alzheimer’s drug
18 June 2021 - Data from clinical trials of three experimental Alzheimer’s disease drugs expected to start emerging next year ...
Posted by Michael Wonder on 10 Jun 2021
Core patient reported outcomes in cancer clinical trials
9 June 2021 - This guidance provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes ...
Posted by Michael Wonder on 25 May 2021
Adjusting for non-adherence or stopping treatments in randomised clinical trials
25 May 2021 - Randomised clinical trials allocate individuals to different treatments, or, more generally, to interventions and comparators, to determine ...
Posted by Michael Wonder on 24 May 2021
Adjusting for covariates in randomised clinical trials for drugs and biological products
20 May 2021 - This guidance represents FDA’s current thinking on adjusting for covariates in the statistical analysis of randomised clinical ...
Posted 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 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 ...