Blog
RSS FeedPosted by Michael Wonder on 08 Oct 2023
Clinical studies: you can see better with the second arm
6 October 2023 - In a statement to the EMA, the IQWiG emphasised that single-arm studies may be sufficient for ...
Posted by Michael Wonder on 28 Sep 2023
The use of historical controls in clinical trials
28 September 2023 - A randomised clinical trial is frequently the preferred research design for testing new medical treatments. Randomisation helps ...
Posted by Michael Wonder on 04 Sep 2023
The changing landscape of clinical trials in Australia
4 September 2023 - Examining the clinical trials landscape in Australia is important for governance and to expand knowledge about trial ...
Posted by Michael Wonder on 23 Aug 2023
Futility in clinical trials
31 July 2023 - The primary objectives of a confirmatory clinical trial, namely a clinical trial conducted with the intention of ...
Posted by Michael Wonder on 16 Aug 2023
In a rare move, FDA threatens to fine a company for failing to report clinical trial results
16 August 2023 - For only the fifth time, the FDA recently threatened to fine a company or clinical trial ...
Posted by Michael Wonder on 25 Jul 2023
Paving the way towards coordinated clinical trials in public health emergencies in the EU
25 July 2023 - EMA has published a report from a workshop that collected insights and suggestions for possible EU level ...
Posted by Michael Wonder on 20 Jun 2023
Evidence of lack of treatment efficacy derived from statistically non-significant results of randomised clinical trials
20 June 2023 - Many randomised clinical trials yield statistically non-significant results. Such results are difficult to interpret within the dominant ...
Posted by Michael Wonder on 06 Jun 2023
FDA announces additional steps to modernise clinical trials
6 June 2023 - Agency requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial ...
Posted by Michael Wonder on 02 Jun 2023
FDA considers new efficacy endpoint for diabetes drugs
31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for ...
Posted by Michael Wonder on 30 May 2023
The FDA is ignoring patients in clinical trials
28 May 2023 - Imagine having two daughters who both have a rare disease and watching them struggle — to ...
Posted by Michael Wonder on 27 May 2023
Adjusting for covariates in randomized clinical trials for drugs and biological products
26 May 2023 - This final guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomised ...
Posted by Michael Wonder on 22 May 2023
The role of disclosures: helping to understand oncology clinical trial endpoints
18 May 2023 - FDA researchers wanted to see whether consumers understand oncology endpoints in DTC television ads, and whether disclosures ...
Posted by Michael Wonder on 27 Apr 2023
CADTH, ICER, and NICE release joint position statement on redacting clinical data awaiting publication
24 April 2023 - The position statement is a step toward greater transparency of unpublished data and a tangible outcome ...
Posted by Michael Wonder on 23 Apr 2023
EMA addresses considerations for single-arm trials
21 April 2023 - A new reflection paper from the EMA offers some suggestions to sponsors on how to design ...
Posted by Michael Wonder on 27 Mar 2023
Clinical trial considerations to support accelerated approval of oncology therapeutics
24 March 2023 - The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious ...