Blog
RSS FeedPosted 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 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 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31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for ...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 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 ...
Posted by Michael Wonder on 27 Mar 2023
FDA outlines plan for digital health technologies for clinical trials
24 March 2023 - The US FDA plans to hold at least one public meeting and release several guidances on digital ...
Posted by Michael Wonder on 28 Feb 2023
My son’s time is running out due to a rare disease. The FDA needs to add more clinical trial flexibility.
28 February 2023 - My toddler, Wheeler, will probably not live to adulthood. Juvenile Batten disease — he has the ...
Posted by Michael Wonder on 16 Feb 2023
FDA to require diversity plan for clinical trials
16 February 2023 - US regulatory agency makes ‘big change’ to increase the number of participants from under-represented groups in drug ...
Posted by Michael Wonder on 15 Feb 2023
US Government payer funded trials to address oncology's drug dosing conundrum: a Congressional call to action?
13 February 2023 - Since the mid 20th century, cancer drug development has been guided by the assumption that more is ...
Posted by Michael Wonder on 24 Jan 2023
Sequential, multiple assignment, randomised trial designs
24 January 2023 - An adaptive intervention is a set of diagnostic, preventive, therapeutic, or engagement strategies that are used in ...