Blog
RSS FeedPosted by Michael Wonder on 11 Sep 2021
Representativeness of participants eligible to be enrolled in clinical trials of aducanumab for Alzheimer disease compared with Medicare beneficiaries with Alzheimer disease and mild cognitive impairment
9 September 2021 - In June 2021, the US FDA granted accelerated approval for aducanumab to treat patients with mild cognitive ...
Posted by Michael Wonder on 04 Aug 2021
Collecting patient reported outcomes in cancer clinical trials
3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...
Posted by Michael Wonder on 04 Aug 2021
Interpreting the results of intention to treat, per protocol and as treated analyses of clinical trials
3 August 2021 - Non-adherence in a randomised clinical trial occurs when study participants do not follow the randomly assigned treatment ...
Posted by Michael Wonder on 02 Aug 2021
Working towards harmonised access to clinical trial data across European drug regulatory agencies
31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the ...
Posted by Michael Wonder on 02 Aug 2021
Six month countdown to go live for the Clinical Trials Information System
2 August 2021 - The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and ...
Posted by Michael Wonder on 26 Jul 2021
FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues
26 July 2021 - Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several ...
Posted 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 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 ...