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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →