FDA’s Clinical Trial Inclusion Policy Sold As Mild And Gentle
This article was originally published in The Pink Sheet Daily
Bob Temple says encouraging broader populations in clinical trials should not affect study size or enrichment designs.
You may also be interested in...
US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’
Acting FDA commissioner says there are a lot of strong forces in the research and pharma industries that could curb efforts to make pandemic-related clinical trial reforms permanent.
Should US FDA Refuse Approval If Women Under-Represented In Clinical Trials?
Idea suggested during 'Great Debate,' but agency official says no adlibbing is allowed in the regulations.
Large Simple Trials Need FDA Boost, IoM Report Says
“Clear specific guidance” from the agency would help close the perception gap between what types of data industry thinks FDA wants and what the agency actually expects, according to a summary of a 2012 Institute of Medicine workshop.