Blog
RSS FeedPosted by Michael Wonder on 20 Jul 2021
Clinical trial national approach will benefit patients and our economy
20 July 2021 - Medicines Australia welcomes the clinical trial ‘one-stop-shop’ consultation, recently announced by the Australian Commission on Safety ...
Posted by Michael Wonder on 06 Jul 2021
MHRA releases guidance in collaboration with Health Canada to improve patient safety in clinical trials through improving the quality of Development Safety Update Reports
6 July 2021 - The Medicines and Healthcare products Regulatory Agency and Health Canada have published guidance to improve the safety ...
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 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 ...