Blog
RSS FeedPosted 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31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for ...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24 April 2023 - The position statement is a step toward greater transparency of unpublished data and a tangible outcome ...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 ...
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 25 Mar 2023
MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years
21 March 2023 - The legislative changes will help to make the UK one of the best countries in the world ...
Posted by Michael Wonder on 05 Mar 2023
Replacing RCTs with real world data for regulatory decision-making: a self-fulfilling prophecy?
2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials for closing knowledge gaps ...
Posted by Michael Wonder on 02 Mar 2023
Efficient RCTs with real world data for benefit assessments: accelerating evidence-based care
2 March 2023 - Together with colleagues from the Belgian HTA agency KCE, three employees of IQWiG in the BMJ are ...
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 20 Feb 2023
ABPI response to Lord O'Shaughnessy review
20 February 2023 - The Office for Life Sciences has today announced that Lord James O’Shaughnessy will conduct a review ...
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 ...